Wednesday, December 31, 2008

Boys Reversible Vests Recalled by Bon-Ton Stores Due to Choking Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Boy's Reversible Vests

Units: About 5,000

Retailer: The Bon-Ton Department Stores Inc., of York, Pa.

Hazard: The zipper tabs on these vests fail to meet the children's torques test standards, posing a choking hazard to children.

Incidents/Injuries: None reported.

Description: This recall involves the "Ruff Hewn" reversible vests for boys sold in toddler (style # F821235) and 4 through 7 sizes (style # F841235). The vests are brown and reverse to a camouflage print. "Ruff Hewn" is printed on the tag found in the left pocket of the brown side and on the price tag. The style number is printed on the price tag.

Sold at: Bon-Ton, Bergner's, Boston Store, Elder-Beerman, Herberger's, Younkers, and Carson Pirie Scott stores nationwide and Parisian in the Detroit area from July 2008 through November 2008 for about $30.

Manufactured in: India

Remedy: Consumers should immediately take these vests away from children and return them to the store where purchased for a full refund.

Consumer Contact: For additional information, contact Bon-Ton toll-free at (866)798-2875 anytime or visit the company's Web site at www.bonton.com

Faulty Instructions Prompt Recall of Electrical Wiring How-to-Books by The Taunton Press; Shock Hazard to Consumers

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Wiring a House, 3rd Edition and Wiring Complete, Expert Advice from Start to Finish Instructional Books

Units: About 64,000

Publisher: The Taunton Press, of Newtown, Conn.

Hazard: The books contain several errors in the technical diagrams that could lead consumers to incorrectly install or repair electrical wiring, posing an electrical shock hazard to consumers.

Incidents/Injuries: None reported.

Description: The recall involves the 3rd Edition of Wiring a House. The paperback book’s cover is white and yellow and has a photograph of a man wiring a panel. ISBN #978-1-56158-942-5 is printed on the back cover. Wiring Complete, Expert Advice from Start to Finish is paperback and has a green, black and white cover that shows hands wiring an electrical wall receptacle.

Sold at: Home improvement stores, book stores, and various other retailers nationwide from February 2008 through November 2008 for about $25.

Manufactured in: United States

Remedy: Consumers should immediately stop using the books and return them to the place of purchase for a full refund.

Consumer Contact: For additional information, contact Taunton at (800) 477-8727 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site www.taunton.com .

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Wednesday, December 24, 2008

KRC Food Trading Inc. Issues Allergy Alert On Undeclared Eggs in Fish Cake Sushi

KRC Food Trading Inc is recalling its Fish Cake sushi with production date of December 19 and December 22 due to the label not declaring eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

The Fish cake Sushi was distributed in California in coffee shops, bakeries, and Korean markets in Los Angeles, CA including two retail stores owned by the firm.

The Fish Cake Sushi comes in a 14-ounce package and is labeled as being distributed by Min Sok Chon. The production date can be found on a yellow stick-on label.

The recall was initiated after it was discovered that the Fish Cake Sushi counting egg was distributed in packaging that did not reveal the presence of egg.

Consumers who have purchased this product are urged to return it to the location of purchase for a full refund. Consumers with questions may contact the company at 1-213-388-8215 its business hours is from 7:00 AM to 7:00 PM. Its contact person is Ms Joanna Kim.

Tuesday, December 23, 2008

Woodstock Percussion Inc. Recalls Toy Drums Due to Violation of Lead Paint Standard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Calypso Steel Drums

Units: About 2,800

Manufacturer: Woodstock Percussion Inc., of Shokan, N.Y.

Hazard: Surface paint on the recalled toy drums contain excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recalled steel drum is made of steel and comes with two wooden drum sticks and a wooden stand. The sides of the drums are painted red. The drum pan is painted black with silver markings to show the location of notes. Each rim is stamped with a #5 or #6. Not all drums stamped with a #5 are affected by this recall.

Sold by: Mail order catalogues, Web sites and retail stores nationwide from December 2006 through December 2007 for between $50 and $100.

Manufactured in: Trinidad

Remedy: Consumers should immediately take the recalled steel drum away from children and return it to Woodstock Percussion for a replacement drum and a $5 credit or payment.

Consumer Contact: For more information, consumers can contact Woodstock Percussion toll-free at (866) 543-2848 anytime, e-mail safety@chimes.com, or visit the firm's Web site at www.woodstockpercussion.com

Munire Recalls "Newport Rubbed Black" Cribs and Matching Furniture Due to Violation of Lead Paint Standard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Newport Rubbed Black 4-in-1 Cribs and Matching Furniture

Units: About 3,000 Cribs and 6,000 Matching Furniture Pieces

Manufacturer: Munire Furniture Inc, of Piscataway, N.J.

Hazard: The red paint which is underneath the black finish paint on some of the cribs and matching furniture exceeds federal lead limits. If ingested by young children lead can cause adverse health effects.

Incidents/Injuries: Munire has received one report of a child ingesting the paint. The child was diagnosed with lead poisoning.

Description: The recalled cribs and furniture are made of wood and have a rubbed black finish. Only the "Newport Rubbed Black" cribs and matching furniture manufactured in Indonesia between April 2006 and November 2008 are included in this recall. The model number, date, and country of manufacture are printed on the label attached to the side panel of the crib and the date of manufacture is on the back panel of the furniture. Models listed below are included in the recall:

Model and Name
7900 Newport Lifetime Crib
7918 Hutch for Combo & Double Dresser
7915 Mirror
7908 Combo
7902 Nightstand
7907 Conversion Kit for Lifetime Crib
7905 5 Drawer Dresser
7929 Armoire
7975 Guardrail for Lifetime Crib
7906 Double Dresser
7914 Bookcase
7901 Newport OldeWorld Crib

Sold at: Specialty furniture stores nationwide from April 2006 through November 2008 for about $600 for the crib and the matching furniture pieces were sold between $700 and $1,000. Additional accessories were sold for about $170.

Manufactured in: Indonesia

Remedy: Consumers should immediately stop using the products and contact Munire Furniture to receive a replacement coupon which will entitle consumers to exchange the products for another product free of charge.

Consumer Contact: For more information, call Munire Furniture toll-free at (866) 586-9639 between 9 a.m. and 6 p.m. ET Monday through Friday, or visit the firm's Web site at www.munirefurniture.com .

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Gardener's Supply Company Recalls Candle-Powered Carousels Due to Fire Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Candle-Powered Carousels

Units: About 1,500

Importer: Gardener's Supply Co., of Burlington, Vt.

Hazard: The candle holder placement on the base of the carousels is too close to the structure, allowing the candle flame to come in contact and ignite different parts of the carousel, including the fans, trees and deer, posing a fire hazard.

Incidents/Injuries: The firm has received three reports of the carousels catching on fire. No injuries have been reported.

Description: The recalled candle carousels are made of yellow pine and stainless steel and measure about 9 inches in diameter by 13 inches high. The candle measures about 4 inches high. The candle carousels generate heat which rotate the fan blade and can cause the center platform to spin. The carousel is made of wood with cutouts of trees and deer.

Sold at: Gardener's Supply retail stores in Burlington and Williston, Vt. and Gardener's supply catalog distributed nationwide and on the internet at www.gardeners.com from September 2008 through November 2008 for about $30.

Manufactured in: China

Remedy: Consumers should stop using the carousel immediately and return them to the store where purchased for a full refund. Consumers also can mail the product to Gardener's Supply Returns, 5 New England Drive, Essex Junction, VT 05452.

Consumer Contact: For additional information, contact Gardener's Supply Co. at (800) 876-5520 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the firm's Web site at www.gardeners.com

Foursquare Recalls Hooded Youth Jackets with Drawstrings Due to Strangulation Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Foursquare Hooded Jackets

Units: About 1,300

Distributors: Foursquare Outerwear, of Irvine, Calif.

Hazard: The jackets have a drawstring through hood which poses a strangulation hazard to children. In February 1996, CPSC issued guidelines (pdf) to help prevent children from strangling or getting entangled on the neck and waist by drawstrings in upper garments, such as jackets and sweatshirts.

Incidents/Injuries: None reported.

Description and Models: This recall involves the Foursquare hooded jackets with drawstrings in boys and girls sizes XS, S, M, L, and XL. The jackets come in various colors and patterns and have a logo showing four adjacent, vertically offset squares on the sleeve, waist, breast and/or back of the jacket, depending on the specific model.

Sold at: Snowboard, ski and sportswear stores nationwide from June 2008 through November 2008 for about $125.

Manufactured in: Taiwan

Remedy: Consumers should immediately remove the drawstring from the sweatshirts to eliminate the hazard, or contact Foursquare for a full refund.

Consumer Contact: For additional information, contact Foursquare toll-free at (877) 327-4484 9 a.m. and 5 p.m. PT, visit Foursquare's Web site at www.foursquareouterwear.com, or e-mail the firm at info@theprogram.com

Atomic Skis USA Recalls Ski Bindings Due to Unexpected Release, Fall Hazard

/PRNewswire-USNewswire/ -- The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of product: Alpine Ski Bindings

Units: About 125,000 (an additional 1.0 million were sold outside the U.S.)

Manufacturer: Atomic Skis GmbH, of Austria

Hazard: The heel housing of the bindings can crack, causing the binding to release unexpectedly. This can cause the skier to lose control or fall and suffer injuries.

Incidents/Injuries: The firm has received four reports of injuries, including a concussion and injuries to the shoulder and knee from falls.

Description: The recall affects the heel components of the following Atomic alpine ski bindings: Race 310, Race 412, RaceRace 310, RaceRace 412, Xentrix 310, Xentrix 311, Xentrix 412, C310, C311, C412, CR 310, CR 412, R 310, R 412, SX 310, SX 412, Device 311, Device 412, Centro 310, Centro 412, and Dynamic ADX 312, RD10, X412, Centro 412. The recall includes only those bindings manufactured from 1998 through 2002. The year of manufacture can be located on the underside of the heel lever.

Sold at: Authorized Atomic USA ski dealers nationwide from 1998 through 2005 for between $150 and $350.

Manufactured in: Austria

Remedy: Consumers should stop using these ski bindings immediately and return them to any authorized Atomic Ski dealer for a free inspection and replacement of the heel component, if needed.

Consumer Contact: For additional information, contact Atomic Ski USA toll-free at (888) 535-7555 between 8 a.m. and 4 p.m. MT Monday through Friday; e-mail consumerserviceUS@atomicsnow.com; or visit the firm's Web site at www.atomicsnow.com.

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Hallmark Recalls Jumbo Snow Globes Due to Fire Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Jumbo Snowman Snow Globes

Units: 7,000

Importer: Hallmark Cards Inc., of Kansas City, Mo.


Hazard: When exposed to sunlight, the snow globes can act as a magnifying glass and ignite nearby combustible materials, posing a fire hazard.

Incidents/Injuries: Hallmark has received two reports of the snow globes igniting nearby materials. No injuries have been reported.

Description: This recall involves a Hallmark Jumbo Snow Globe in the shape of a snowman with model number 1XAG5093 and UPC code 795902066666. The snow globe measures 11 by 12 by 17 inches. The model number and the UPC code can be found on the back of the hangtag.

Sold at: Hallmark Gold Crown stores nationwide from October 2008 through November 2008 for about $100.

Manufactured in: China

Remedy: Consumers should immediately remove the snow globe from exposure to sunlight and return it to any Hallmark Gold Crown store for a full refund.

Consumer Contact: For additional information, contact Hallmark at (800) 425-5627 between 8 a.m. and 5 p.m. CT Monday through Friday or visit the firm's Web site at www.hallmark.com.

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Saturday, December 20, 2008

Dorsey Marketing Inc. Voluntarily Recalls Three Gourmet Market Cocoa Products: 120126, 120129, 120144

Dorsey Marketing Inc. (DMI) of Ville St. Laurent, Quebec, Canada, is voluntarily recalling the following three G&J Gourmet Market cocoa products because these products may contain melamine:

1. G&J Hot Cocoa Stuffer Item 120144 (UPC 061361201444). This hot cocoa product was sold in small green and blue boxes with a backer card, candy cane and marshmallows.
2. G&J His and Hers Hot Cocoa Set Item 120129 (UPC 489702201296). This cocoa product was sold with 2 ceramic mugs in a brown box.
3. G&J Cocoa item 120126, sold in 2 flavors: French Vanilla Cocoa and Double Chocolate Cocoa
1. G&J French Vanilla Cocoa (UPC 061361201260). This product was sold in a small green bag with a whisk attached.
2. G&J Double Chocolate Cocoa (UPC 061361201260). This product was sold in a small pink bag with a whisk attached.

No injuries have been reported and only a few samples have, in fact, been found to include melamine. However, DMI is proceeding with this recall in the interest of public health and the safety of American consumers.

The above recalled products were imported into the United States by DMI and distributed nationwide to retailer Big Lots during the weeks of September 22, 2008 and September 29, 2008 and to retailer Shopko during the week of October 10, 2008.

Consumers who purchased these products are urged to return them to the place of purchase for a refund. Consumers with questions may contact Tim Acheson of DMI Monday through Friday, excluding holidays, between 9:00 AM and 5:00 PM EST toll free at 1-888-645-1053 or email recall@dmi-global.com.

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Friday, December 19, 2008

Children's Jewelry Sold Exclusively in Hawaii Recalled by Aloha 808 Trading Due to Risk of Lead Exposure

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Children's Jewelry

Units: About 12,800

Importer: Aloha 808 Trading, of Honolulu, Hawaii

Hazard: The recalled jewelry contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: This recall involves eight styles of silver-colored metal jewelry: flower ear ring, three flower pendant, necklace with red flower and metal leaf pendant, and miniature sandals in aqua, purple, green, orange and turquoise.

Sold at: Small retail stores and kiosks in Honolulu, Hawaii from April 2008 through November 2008 for between $2 and $5.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled jewelry and contact Aloha 808 Trading for a refund or exchange.

Consumer Contact: For additional information, contact Aloha 808 Trading collect at (808) 923-3660 between 9 a.m. and 5 p.m. PT Monday through Friday.

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Evenflo Recalls Majestic(tm) High Chairs Due to Fall and Choking Hazards

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Evenflo Majestic(tm) High Chairs

Units: About 95,000

Manufacturer: Evenflo Company Inc., of Miamisburg, Ohio

Hazard: Plastic caps and metal screws on both sides of the high chair can loosen and fall out, posing both fall and choking hazards to children. Plastic caps and screws that become loose and fall out can cause the seatback to suddenly fall back or detach from the high chair. Children can fall out or collide with objects and suffer broken bones, abrasions, cuts and bruises. Detached plastic caps and metal screws also pose a choking hazard to children.

Incidents/Injuries: Evenflo has received 140 reports of seatbacks reclining, falling back and/or detaching unexpectedly, which resulted in at least 47 reports of bumps and bruises to the head, two reports of broken bones, and at least 45 reports of other injuries including abrasions, cuts, and bruises. Evenflo has received more than 1,000 reports of plastic caps and screws falling out of the high chairs, including seven incidents in which caps and screws were found in children's hands or mouths but were removed before choking occurred.

Description: The recall involves Evenflo Majestic(tm) high chairs made before January 23, 2007. The recalled high chairs have the following model numbers: 3001395A, 3001583, 3001633A, 3001669, 3001700A, 3001713, 3001713A, 3001730A, 3001732, 3001732A, 3001733, 3001742, 3001742A, and 3001756. The model number and production date can be found on a white label on the seatback. "Evenflo" is printed on the label and on the push button on the front of the tray.

Sold at: Juvenile product and mass merchandise stores nationwide, including Toys R Us, Babies R Us, Burlington Coat Factory and Shopko, and on-line at walmart.com from January 2006 through May 2007 for between $80 and $110.

Manufactured in: China

Remedy: Consumers should immediately stop using the high chairs and contact Evenflo to receive a free repair kit.

Consumer Contact: For additional information, contact Evenflo at (800) 233-5921 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit www.majestichighchair.com .

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Thursday, December 18, 2008

Xtreme Toy Zone Recalls Toy Dinosaurs Due to Violation of Lead Paint Standard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: "Dinosaur Epoch" Toy Dinosaurs

Units: About 480

Importer: Xtreme Toy Zone, of Los Angeles, Calif.

Hazard: Surface paint on the toy dinosaurs can contain excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recalled "Dinosaur Epoch" Toy Dinosaurs are battery-operated dinosaurs that move and make sounds. The recall includes the orange-colored "Dinosaur Brachiosaurus" (model #1033) and the green, yellow and orange-colored "Dinosaur Carnotaurus" (model #1030). The model number can be located on the toy's battery cover.

Sold at: Xtreme Toy Zone's Web site from May 2008 through October 2008 for between $15 and $20.

Manufactured in: China

Remedy: Consumers should immediately take the recalled toys away from children and contact Xtreme Toy Zone for a refund or exchange.

Consumer Contact: For additional information, contact Xtreme Toy Zone collect at (213) 237-9983 between 9 a.m. and 5 p.m. PT Monday through Friday, or visit the firm's Web site at www.xtremetoyzone.com .

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Regal Lager Recall to Replace Phil & Teds Strollers Due to Fall Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Phil & Teds Dash Buggy Strollers

Units: 1,600

Importer: Regal Lager Inc., of Kennesaw, Ga.

Hazard: The frame handle could fail to latch properly and break, posing a fall hazard to small children.

Incidents/Injuries: None reported.

Description: This recall involves Phil & Teds Dash Buggy strollers with article #7-1080005 (red) and article #7-10080005 (black). The strollers have a metal frame with three wheels, a cloth seat, and a canopy. The Phil & Teds logo is located on the crotch piece of the harness. The article number can be found on the safety strap hanging from the handle.

Sold through: Various independent juvenile specialty stores and online from July 2008 through September 2008 for between $500 and $600.

Manufactured in: China

Remedy: Consumers should stop using this stroller immediately and contact the company for a replacement stroller frame.

Consumer Contact: For additional information, contact Regal Lager at (800) 593-5522 or visit the Company's Website at www.regallager.com .

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Grease Removers Recalled by Fantastic Distributors Due to Chemical Burn Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: "Bagi Shumanit" Super Cold Grease Removers

Units: About 245,000

Importer: Fantastic Distributors, of Brooklyn, N.Y.

Hazard: Direct contact with this substance can cause burns to consumers' skin and eyes. The product lacks required special packaging and warning label.

Incidents/Injuries: None reported.

Description: "Bagi Shumanit" Super Cold Grease Remover is packaged in a white 26.4 fl oz. (750 ml) bottle with a trigger sprayer. This product is intended to clean grease from ovens and other cooking surfaces.

Sold at: Various grocery stores in New York, New Jersey and Connecticut from April 2000 through September 2008 for about $5.

Manufactured in: Israel

Remedy: Consumers should immediately pour any remaining product into the toilet, using care to avoid splashing. Consumers should return the empty bottle to the store where the product was purchased for a full refund.

Consumer Contact: For additional information, contact Fantastic Distributors collect at (718) 485-1300 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.fantasticinc.com

Tuesday, December 16, 2008

FDA Announces Class I Recalls of Two Unapproved Devices

The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

"These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.”
Vibrational Integrated Bio-photonic Energizer device

On April 11, 2008, the FDA issued a warning letter to VIBE Technologies stating that the agency's November 2007 inspection of the facility showed that the company had not obtained FDA marketing approval or clearance for the Vibrational Integrated Bio-photonic Energizer (VIBE device), which claims to treat cancer, infections, and depression. The FDA also cited the company for substantial deviations from the current Good Manufacturing Practice/Quality System regulation.

VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.

The FDA is aware of information that suggests that the VIBE device has been used in cancer patients. There is one death that occurred in a patient who used this device. However, FDA has not verified that there is any association between the death and the VIBE device.
HLX8 device

In June 2008 FDA inspected Nebion, LLC, which revealed that the company had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation.

Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval.

Nebion's first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that they will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.

Under federal law, products that claim to diagnose a disease or condition, cure, mitigate, treat or prevent disease, or that are intended to affect the structure or function of the body are devices subject to FDA jurisdiction and may require FDA approval or clearance prior to marketing. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. FDA clearance is for lower risk devices that are shown to be as safe and effective as a similar device already on the market.

Neither VIBE Technologies nor Nebion has demonstrated to the FDA that their device is safe and effective at curing or treating diseases as claimed.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

Health care professionals and patients can obtain further details about the recalls from VIBE Technologies at 970-356-9594 or Nebion LLC, at 310-215-6400.

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Monday, December 15, 2008

Kashi Company Issues Allergy Alert on Undeclared Milk in Kashi® GOLEAN® Powder Chocolate Energy Shake Mix

Kashi Company of LaJolla, CA is recalling a limited number of canisters of Kashi GOLEAN Powder Chocolate Energy Shake Mix because they contain undeclared milk. People who have an allergy or severe sensitivity to milk, run the risk of serious or life-threatening allergic reaction if they consume this product.

The product was distributed to grocery, health food, pharmacy and on-line retailers nationwide.

The product is packaged in a 14.8 oz – canister with a bar code of 18627 71000. Canisters with a Better if Used by Date stamped on the bottom of the canister between the dates of JAN 17 2009 and NOV 15 2009 are included in this alert.

No allergic reactions have been reported to date.

The recall was initiated after it was discovered that a limited number of Kashi GOLEAN Chocolate Energy Shake mix canisters did not declare whey caseinate, a milk ingredient, in the ingredient statement.

Consumers who have a Kashi GOLEAN Chocolate Energy Shake Mix canister with a bar code of 18627 71000 and Better if Used by Date stamped on the bottom between the dates of JAN 17 2009 and NOV 15 2009 should call the Kashi Consumer Response center at 1-877-747-2467.

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Sunday, December 14, 2008

Urgent: Food Product Recall Re: Imitation Cream Cheese and Low Protein Peanot Butter™

Cambrooke Foods® is announcing a voluntary recall of all batches of the following products:

* Cheddar Wizard Low Protein Imitation Cream Cheese (SKU 10310; 8 oz. jar);
* Herb & Garlic Low Protein Imitation Cream Cheese (SKU 10308; 8 oz. jar); and
* Plain Low Protein Imitation Cream Cheese (SKU 10306; 8 oz. jar).

Cambrooke Foods® is undertaking this voluntary recall as a precaution because some of these products may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

For the above-listed Imitation Cream Cheese products, Listeria monocytogenes was detected through routine batch testing of product at a company facility before it was sent to customers. These batches of Imitation Cream Cheese products were destroyed. While no reports of adverse events have been reported with any product shipped to our customers, we are taking the precautionary step to recall all Imitation Cream Cheese products, regardless of batch number.

To be abundantly cautious and proactive, Cambrooke Foods® is also conducting a market withdrawal of all batches of:

* Low Protein Peanot Butter™ (SKU 10809; 16 oz. jar).

This product is being withdrawn because it is produced in the same facility and using the same machinery used to produce the Imitation Cream Cheese products. Testing has not confirmed Listeria contamination in any batch of Low Protein Peanot Butter™ nor have any adverse events been reported as a result of its consumption. No other Cambrooke Foods™ product is produced using this machinery.

Cambrooke Foods™ is working directly with the Food and Drug Administration (FDA) to investigate the cause of this contamination. Cambrooke Foods™ has voluntarily suspended manufacture and distribution of these products pending its investigation.

If you have purchased any of these products since May 2008, please take the following actions immediately:

1. discard all units of these products remaining in your possession;

2. complete the online Recall Response Form

If you have questions or require further information, contact Cambrooke Foods® toll-free 866-456-9776, ext. 1015, or via email at safetyfirst@cambrookefoods.com

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Friday, December 12, 2008

FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish

The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel & Charles LeBlanc Fisheries Ltd., CAP-PELÈ, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers should not consume the product.

C. botulinum toxin can cause botulism, a serious and sometimes life-threatening condition. The toxin cannot be removed by cooking or freezing.

The fish were imported into the United States and sent to these Florida distributors:

Quirch Foods Inc.

Den-Mar Exports LLC

Dolphin Fisheries Inc.

Labrador & Son Food Products Inc.

The fish were packed in 30-pound, white plastic pails with green plastic lids. The brand name "Michel & Charles LeBlanc Fisheries Ltd.," appears on the side of the pails, as does the phrase "Product of Canada." One hundred seventy-three (173) 30 lb. pails of fish were distributed. The fish may have been repacked or sold loose by retailers in Florida.

The FDA considers any ungutted fish over five inches in length that is salt-cured, dried, or smoked, such as the ungutted, salt-cured alewives/gaspereaux fish, to be adulterated because it could contain the C. botulinum toxin. The Florida Department of Agriculture and Consumer Services discovered the ungutted alewives/gaspereaux fish from Michel & Charles LeBlanc Fisheries Ltd. being sold in stores and alerted the FDA. The FDA prohibits the sale of this adulterated product in the United States.

To date, there have been no reported illnesses associated with this product. However, consumers who have purchased ungutted, salt-cured alewives/gaspereaux fish in Florida should contact the place of purchase to determine if the fish they bought originated from Michel & Charles LeBlanc Fisheries Ltd. If the fish were from this company or if the source of the fish cannot be determined, consumers should immediately discard the fish and any foods made with these fish.

Symptoms of botulism poisoning can begin from six hours to 10 days after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth and muscle weakness that affects first the shoulders and then moves progressively down the rest of the body. Botulism poisoning can also cause paralysis of the breathing muscles which can result in death unless assistance with breathing (mechanical ventilation) is provided.

Individuals who show these symptoms and who may have recently eaten alewives/gaspereaux fish should seek immediate medical attention.

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Thursday, December 11, 2008

Propane Gas Fireplace Inserts Recalled by Wolf Steel Due to Laceration Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Napoleon Propane Gas Fireplace Inserts

Units: About 1,200

Manufacturer: Wolf Steel USA, of Crittenden, Ky.

Hazard: Delayed ignition due to a build-up of propane gas can cause the insert's glass cover to break, posing a laceration hazard to consumers.

Incidents/Injuries: Wolf Steel has received one report of a consumer who suffered minor lacerations when the glass cover shattered.

Description: This recall involves Napoleon propane GDI44 gas fireplace inserts. Model number GDI44 is located on the front cover of the operating instructions or on the rating label found behind the right side panel next to the insert's viewing glass. The glass size is 36" wide and 22" high. Napoleon natural gas GDI44 inserts are not affected by this recall.

Sold at: Authorized Napoleon fireplace hearth dealers nationwide from July 2002 through September 2008 for about $2,000.

Manufactured in: Canada

Remedy: Consumers should immediately stop using the fireplace and contact Wolf Steel to receive a free repair kit.

Consumer Contact: For additional information, contact Wolf Steel toll-free at (866) 539-2039 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the firm's Web site at www.napoleonfireplaces.com .

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The Toro Company Reannounces Recall of Electric Blowers Due to Projectile Hazards

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Toro Power Sweep Electric Blowers

Units: About 900,000

Manufacturer: The Toro Company, of Bloomington, Minn.

Hazard: The blower's impeller, which is a rotating component on the blower, can break, resulting in pieces of plastic flying out of the blower. This poses a risk of serious injury to the user or a bystander.

Incidents/Injuries: Toro has received 162 reports of broken impellers, including 28 reports of minor cuts and bruises resulting from projected impeller pieces.

Description: The recall involves Toro Power Sweep electric blower model 51586 that was manufactured between 2000 and 2002. The recalled units have serial numbers that range between 000055100 and 220255609. There are two decals on the main housing of the blower. One decal reads, "TORO Power Sweep" and the decal on the opposite side of the blower contains the model number and serial number (shown by the letter "A" in the picture below). The recalled units can be identified by a black impeller fan, which can be seen through the air inlet screen on the bottom of the unit.

Sold through: Toro dealers and various mass retailers nationwide including The Home Depot, Lowes, Target and K-Mart stores from January 2000 through late December 2002 for about $32.

Manufactured in: United States

Remedy: Consumers should stop using the recalled blowers immediately and contact Toro to receive a replacement blower.

Consumer Contact: For more information, contact Toro at (888) 279-3191 between 7:30 a.m. and 7 p.m. CT Monday through Friday or 8 a.m. and 6 p.m. Saturday. Consumers can also visit the Toro web site at www.toro.com. The Toro Company has notified registered owners directly.

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Wednesday, December 10, 2008

Dill Air Controls Products Announces Voluntary Recall of Automobile Tire Stem Valves

(BUSINESS WIRE)--Today, Dill Air Controls Products announced the voluntary recall of automobile tire stem valves sold in the United States between November 2006 and July 2007. The snap-in rubber valve stems, manufactured by Topseal (Shanghai) Auto-Parts Co., Ltd., in Shanghai, China, and imported and distributed by Dill Air Controls Products LLC (“Dill”) under the “Dill ACP” brand name, may lack the required additive to protect the rubber against deterioration from ozone exposure. As a result, affected valve stems, when subjected to high levels of ozone, may weather and crack earlier than normal for this product. Over time, such a crack could progress to the point that it leaks air resulting in a loss of tire pressure. Loss of tire pressure can result in a flat tire and/or loss of vehicle control.

Dill advises all consumers that bought new tires between November 2006 and July 2007 containing the unique Dill valve cap to have their valve stems inspected for cracks. Dill ACP valve stems from this time period exhibiting cracks in the rubber will be replaced at no cost to the consumer.

Consumers can check their own valves by flexing the valve (located where one inflates the tire) outwards toward the tire and inspecting the area where the valve meets the tire rim, or they can simply return to the place they purchased their tires for professional inspection. Data collected to date indicates that, by this time, cracking will be visible on any of the recalled valves likely to exhibit cracking. If consumers are unable to return to the point of purchase, they can have their valves inspected at any participating Sears Automotive Center, Tire Kingdom, Big O Tires, Les Schwab Tire Center, NTB or Merchant’s Tire. For more information please visit www.tirevalverecall.net or call 888-364-2982.

Dill has concluded the problem relates to two specific lots manufactured in July 2006. Based on field returns and testing data, Dill believes that the number of valves from the two suspect lots subject to increased cracking risk is 200,000 or fewer. However, the valve stems are not traceable by lot number once the stem is installed; in that light, the recall necessarily includes many more valves than are likely to contain the defect. Consumers who are unsure if their current valve stems were purchased during the recall period should have their valves inspected.

Dill and Topseal have taken numerous corrective actions to prevent a recurrence of this problem, including using an enhanced rubber compound, using an automated inspection system to ensure all additives are mixed properly, performing more testing of the valves in the United States, and re-establishing production of valve stems in the United States.

If consumers experience any difficulty in connection with this recall, they can call the National Highway Traffic Safety Administration Auto Safety Hotline at 1-888-327-4236.

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Tuesday, December 9, 2008

Balanced Health Products, Inc. Expands Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug

Balanced Health Products, Inc. has expanded its voluntarily recall of STARCAPS DIET SYSTEM DIETARY SUPPLEMENT to include additional Lot Numbers 12/2009 – 82866 and 12/2010 - 83801, sold in 30 capsule plastic bottles.

The recall is effective immediately and is being undertaken because these lots of STARCAPS contain an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.

Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Bumetanide has been detected in STARCAPS at a level of 0.8mg per capsule. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide.

The company has received no reports of illness associated with this product.

The company’s investigation to date has indicated that an additional lot of raw material intended for use in the production of STARCAPS which has been stored in sealed drums since the time of its importation into the U.S. is also contaminated with Bumetanide. This information seems to indicate that the contamination occurred at the point of production of the raw material in Lima, Peru.

STARCAPS lot number 12/2009 – 82866, totaling 28,739 consumer-size bottles was distributed nationwide from 3/2006 to 4/2007 through retail outlets and online sales.

STARCAPS lot number 12/2010 - 83801, totaling 28,530 consumer-size bottles was distributed nationwide from 5/2007 to 7/2008 through retail outlets and online sales.

Consumers who purchased STARCAPS Lot Numbers 12/2009 – 82866 and 12/2010 – 83801 should immediately discontinue their use and return it to Balanced Health Products, Inc. at the address on the product label.

Consumers with questions may contact the company at (212) 794-9793 from 10:30am to 4pm EST Monday through Friday.

Consumers who experience adverse events with any lots of this product should seek immediate help from their physician or healthcare provider.

Retail stores are being notified by fax or registered mail to immediately stop all sales and return product to the company.

This recall is being made in cooperation with the US Food and Drug Administration.

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/medwatch.

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Sunday, December 7, 2008

Walgreens Recalls 173 Teddy Bears With Chocolate Bars Sold Since Late September 2008

Walgreens is recalling 173 teddy bears with chocolate bars sold in stores since late September 2008. Analysis by the U.S. Food and Drug Administration found that certain samples of the chocolate provided with the teddy bears were contaminated with melamine. Customers who purchased any of the 173 teddy bears should return them immediately to the Walgreens stores where they were purchased for a full refund.

Walgreens already has instructed stores to stop selling the product, which is specifically described as an approximately 9-inch high Dressy Teddy Bear with 4-oz. Chocolate Bar. The product's UPC number is 047475864485, and the product tag also includes the item number 291332. Walgreens has not received any reports of illness or injury related to this product.

Walgreens takes the safety of its customers seriously and is working with the FDA on this recall. For additional information, visit Walgreens Web site at http://www.walgreens.com/images/pdfs/recalls/TeddyBear_Product_Safety.pdf or contact Walgreens Product Quality department at 847-315-2755, Monday through Friday between 8 a.m. and 4:30 p.m. Central time.

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Friday, December 5, 2008

Mom's Food Products, Inc. Issues Allergy Alert On Undeclared Eggs In Pimento Spread Sandwiches

Mom's Food Products, Inc. of Ft Worth, TX is recalling its Pimento Spread sandwiches with a expiration date of December 15th through the 18th due to the label not declaring an allergen egg yolks. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

There have been no illnesses reported to date.

The recall was initiated after it was discovered the Pimento Spread sandwiches with these dates were incorrectly labeled.

This recall only affects product delivered by Mom's Food Personnel.

The products involved are:

Mom's Pimento Spread 5.0 oz black wedge (UPC 83898 00114) Expiration dates December 15th through 18th.

Consumers who have purchased these items are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Mom's Food Products at 1-800-743-0010.

Limited Recall of LAND O LAKES® Sheep Balancer B136

The Land O'Lakes Purina Feed plant in Lincoln, Neb., has initiated a limited recall of LAND O LAKES® Sheep Balancer B136, packaged in 50-pound bags, due to the potential for a higher than acceptable level of copper. The recall is limited to Sheep Balancer B136 produced at the Lincoln plant on October 8, 2008.

The only product and lot number involved in the recall is:

Formula No. 3LN7
Item No. 1860220
Description Sheep Balancer B-136
Lot Number 8OCT08LNC1

The lot number is found on the sewing strip of each bag.

The product was distributed only to six dealers in southeastern Nebraska and western Iowa.

The presence of copper in higher than acceptable levels can cause health issues and, at high levels, mortality in sheep. To date, no customer complaints have been received involving the product.

Retailers have been contacted and told to immediately quarantine the recalled product and notify customers who purchased the product. Customers should discontinue feeding the product immediately. Customers who purchased these products will receive replacement feed.

For more information on the product recall, contact Customer Service at 1-800-227-8941.

Wednesday, December 3, 2008

OKK Trading Recalls Toy Army Figures Due to Violation of Lead Paint Standard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Army Figures

Units: About 5,400

Importer: OKK Trading, of Los Angeles, Calif.

Hazard: Surface paint on the face of the Army figures contains excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recall involves 7 ½ inch tall plastic toy Army figures. The figures are dressed in Army fatigues and have guns.

Sold at: Dollar type retailers and OKK Trading's Web site www.okktoys.com from June 2008 through September 2008 for about $1.

Manufactured in: China

Remedy: Consumers should immediately take the recalled toys away from children and contact OKK Trading for a full refund or replacement toy.

Consumer Contact: For additional information, contact OKK Trading at (877) 655-8697 between 9 a.m. and 5 p.m. PT Monday through Friday, or visit the firm's Web site at www.okktoys.com (pdf) .

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Doll Clothing Sets Recalled by Manhattan Group Due to Violation of Lead Paint Standard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Groovy Fashions(tm) Sassy Jammies(tm) Doll Clothing Sets

Units: About 9,200

Manufacturer: Manhattan Group, of Minneapolis, Minn.

Hazard: Surface paints on the pajama pants contain excessive levels of lead, which violates the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recalled doll clothing set features a two-piece pajama set, eye mask and slippers. The pajama top is pink satin and the pants are dark brown with multiple-colored flowers printed on them.

Sold at: Mail order, Internet and specialty gift stores nationwide from January 2008 through October 2008 for about $12.

Manufactured in: Indonesia

Remedy: Consumers should take the product away from young children immediately and return them to the store where purchased for a full refund or store credit.

Consumer Contact: For additional information, contact Manhattan Group at (800) 541-1345 between 8 a.m. and 5 p.m. CT Monday through Friday, or visit the firm's Web site at www.manhattantoy.com .

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Hockey Helmets Recalled by Reebok-CCM Due to Head and Neck Injury Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Hockey Helmets

Units: About 1,000

Distributor: Reebok-CCM Hockey U.S. Inc., of Montpelier, Vt.

Hazard: The helmet's chinstrap can unexpectedly disengage while in use. If this happens, the helmet can fall off, posing a head and neck injury risk to consumers.

Incidents/Injuries: None reported.

Description: This recall involves RBK and CCM brand hockey helmets. Helmets included in this recall have a HECC sticker with date code JUN - 2013. HECC stickers and model numbers are located on the back of the helmets. Models included in the recall are:

Brand | Model Numbers | Colors Of The Helmet Shells That Require Inspection | Colors Of The Helmet Shells
That Are Not Affected By This Recall

RBK | HT8K | Black/Black, Black/Silver, White/Silver, Navy, Red, Green, Maroon, Yellow | White/Black, Royal
RBK | HT6K | Black, White, Navy, Red, Royal | None
RBK | HT6K Combo | Black, White, Navy, Red, Royal | None
RBK | HT4K | Black, Navy, Red, Royal | White
RBK | HT4K Combo | Navy, Red, Royal | Black, White
CCM | HTV10 | Yellow | Black, White, Navy, Red, Royal, Green, Maroon
CCM | HTV10 Combo | Black | White, Navy, Red, Royal
CCM | HTV08 | Black, White, Royal, Yellow | Navy, Red, Green
CCM | HTV08 Combo | Black, Medium Black, White, Navy, Royal | Red
CCM | HT692 | White, Navy | Black, Red, Royal
CCM | HT692 Combo | Black | White, Navy, Red, Royal

Sold at: Sporting goods stores nationwide and Internet retailers from May 2008 through July 2008 for between $80 and $200.

Manufactured in: Canada

Remedy: Consumers should immediately stop using and return the helmets to the place of purchase for a free replacement helmet.

Consumer Contact: For additional information, contact Reebok-CCM at (800) 451-4600 between 8 a.m. and 6 p.m. ET Monday through Friday, or visit the firm's Web site at www.reebokhockey.com and http://en.ccmsports.com .

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