Recall Roundup

Thursday, April 30, 2009

Disetronic Medical Systems Inc. (a member of the Roche Group) announces a recall (field corrective action) of the ACCU-CHEK® Spirit insulin pump

Disetronic Medical Systems Inc. (a member of the Roche Group) announces a recall (field corrective action) of the ACCU-CHEK® Spirit insulin pump due to “up” and/or “down” button failures

This notification applies to all ACCU-CHEK® Spirit insulin pumps with serial numbers from SN02119552 through SN10006093 (range of SN shipped to the US). Pumps with serial numbers including and above SN10006094 are not affected and no action is required by users of these pumps.

Disetronic Medical Systems Inc. announced today that it is notifying its customers, distributors and healthcare professionals about a potential defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. The pump’s “up” and “down” buttons are used for changing the program in the menu or to administer additional insulin through a bolus delivery. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. This defect was discovered through the company’s normal quality control monitoring process.

The notifications provide specific actions and details that customers, distributors and healthcare professionals need to take. The pumps in question have serial numbers in the range from SN02119552 through SN10006093 (US market).

If the vibration or acoustic confirmation signal does not occur, the user should disconnect the pump, and switch to a back up pump or an alternative method of insulin delivery. Immediately contact ACCU-CHEK Spirit hotline for a replacement pump or for any other questions regarding this potential defect. Customers should expect the replacement pump within 1-2 business days after contacting ACCU-CHEK Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week.

Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the “up” and/or “down” button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. If you have any questions regarding this recall or questions pertaining to replacement, please contact ACCU-CHEK Spirit hotline at 1-800-778-5095 for further information. This number is available 24 hours a day, 7 days a week.

“We are making this proactive notification to our customers and other interested parties because we have seen a potential for the “up” and/or “down” buttons on some of our pumps to fail over a period of use,” said Dr. Mathias Neumann, Head of Global Quality Management Diabetes Care, Roche Diagnostics. “We are telling our customers to continue to use their ACCU-CHEK Spirit insulin pumps, but monitor the functioning of the “up” and “down” buttons. In addition customers are to continue to monitor their blood glucose as directed by their healthcare professional. Additional actions required by customers are detailed in their notification. We are working with the Food and Drug Administration (FDA), who is aware of this recall and this notification.

We have isolated the root cause of the defect and a fix to the problem has been implemented with SN10006094 and above,” said Dr. Neumann. “The problem is an interrupted electronic contact in the flexible board of the “up” and “down” button module caused over time by stress of this board during repeated pressing of the button.”

Users of an ACCU-CHEK Spirit insulin pump, who are experiencing failure of the “up” and/or “down” buttons, should immediately contact ACCU-CHEK Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week.

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HMI Industries Recalls Floor Cleaners Due to Burn Hazard

Hair Dryers Recalled by Universalink International Trading Due to Electrocution 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: Special and Narita Hair Dryers

Units: About 3,000

Importer: Universalink International Trading Inc., of La Puente, Calif.

Hazard: The hair dryers are not equipped with an immersion protection device to prevent electrocution if the hair dryer falls into water. Immersion protection devices, which prevent electrocution, are required by industry standards for all electric hand-held hair dryers.

Incidents/Injuries: None reported.

Description: This recall involves Special (model EX-1800) and Narita (model TE-263) hair dryers. "Special" or "Narita" and the model number are printed on the dryer. The "Special" hair dryers are brown and the "Narita" hair dryers are white and black and fold up.

Sold at: Various retail stores in California from June 2003 through October 2008 for about $15.

Manufactured in: Taiwan

Remedy: Consumers should immediately stop using the hair dryers and return them to the store where purchased for a full refund.

Consumer Contact: For additional information, contact Universalink International Trading toll-free at (866) 997-6768 between 9:30 a.m. and 5 p.m. PT Monday through Friday, or email the firm at sales@naritausa.com .

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Dinosaur Play Sets Recalled by DND Imports Due to Violation of Lead Paint Standard

Under Armour Recalls Athletic Cups Due To 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: Under Armour Athletic Cups

Units: About 211,000

Importer: Under Armour Inc, of Baltimore, Maryland

Hazard: The cups can break if hit, posing a risk of serious injury hazard to athletes.

Incidents/Injuries: Under Armour has received five reports of cups breaking, including an injury involving cuts and bruising.

Description: This recall involves all athletic cups that have the Under Armour logo, including adult, teen, and youth sizes. The cups were sold individually and as part of a set with compression, slider, or jock shorts.

Sold at: Sporting good stores and Under Armour outlets nationwide and at www.underarmour.com from January 2006 through March 2009 for about $15.

Manufactured in: China

Remedy: Consumers should immediately stop using the athletic cup and contact Under Armour for a $20 voucher for use online or at any Under Armour specialty or outlet store.

Consumer Contact: For additional information, contact Under Armour toll-free at (888) 823-0343 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.underarmour.com/productsafety .

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Wednesday, April 29, 2009

Nature & Health Co. Issues Voluntary Nationwide Recall of Libimax, a Product Marketed as a Dietary Supplement

Nature & Health Co., located in Brea, California, announced today that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name Libimax. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Libimax samples found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Libimax an unapproved drug. FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing.

The recalled Libimax is sold as a 1 capsule individual pack or 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas, and Ohio. The product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product.

Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. The public is encouraged to submit a report of any serious adverse events that occur with the use of Libimax to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Nature & Health Co. is committed to providing accurate information about its products because of concern for the health and safety of consumers. Nature & Health Co. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

No illnesses have been reported to the Company to date in connection with this product.

Consumers should return any unused Libimax, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to contact Nature & Health directly at (714) 257-1800 Monday – Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions.

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Personal Care Products Conducts Nationwide Recall of Non-Acetone Nail Polish Remover Because of Possible Health Risk

Personal Care Products of Bingham Farms, MI is voluntarily conducting a nationwide recall of all lots of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin, 6 fl. oz., UPC 4815592076, because it does not meet product specifications and has the potential to cause chemical burns to the fingers of users.

The product has been sold nationwide in small discount retail stores and retailers are being instructed to remove the product from sale and to return it to Personal Care Products.

Personal Care has received two complaints of burns to the fingers resulting from the use of the product.

Any person who purchased a bottle of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin is urged to return it to the store of purchase for a refund. Consumers with questions may contact Personal Care Products at 1-248-258-1555, Monday through Friday from 9 a.m. until 5 p.m. EDT.

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Tuesday, April 28, 2009

McCormick & Company Recalls Lawry’s Fajitas Spices & Seasonings Packages Due to Unlabeled Milk Ingredients

McCormick & Company, Incorporated (NYSE:MKC) has announced a voluntary recall of Lawry's® Fajitas Spices & Seasonings packages with UPC Code 2150022500 and a “best if used by” date of OCT0110PX62, sold under the Lawry's brand. Lawry's Fajitas Spices & Seasonings packages with this date code contain undeclared milk ingredients. People who have allergies to milk run the risk of serious or life threatening allergic reactions if they consume this product.

The Lawry's Fajita Spices & Seasonings packages were distributed to grocery stores nationally beginning on October 17, 2008. The product is available in 1.27 oz. pouches, and the date code is found printed in black on the back, bottom center of the pouch. The “best if used by” date of OCT0110PX62 is the only date code affected by the recall.

The recall was initiated after it was discovered that product was mispackaged and as a result the ingredient statement on the package did not list milk as an ingredient.

No illnesses or allergic reactions have been reported to date. No other Lawry's products are involved in this recall.

All grocery outlets that sell Lawry's Fajitas Spices & Seasonings packages have been notified to remove the affected product (UPC Code 2150022500 and a “best if used by” date of OCT0110PX62) from their shelves immediately. Consumers do not need to return the product to the store where it was purchased. Instead, consumers are urged to contact Lawry's Consumer Affairs team at 1-800-9-LAWRYS (1-800-952-9797), weekdays from 9:30 AM to 9:00 PM, or weekends from 11:00 AM to 7:00 PM (Eastern Daylight Time) for a replacement or full refund, as well as instructions on what to do with the product.

This recall is being made with the knowledge of the Food and Drug Administration. The company is also issuing an alert through the Food Allergy & Anaphylaxis Network.

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Leg Curl Fitness Machines Recalled by Paramount Fitness Due To Crushing 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: Leg Curl Machines

Units: About 150

Manufacturer: Paramount Fitness Corp., of Los Angeles, Calif.

Hazard: A consumer's hand can become caught between the cylindrical counter weight and the frame of the fitness machine, posing a crushing hazard that can result in lacerations and finger amputation.

Incidents/Injuries: Paramount has received three reports of incidents, including a finger amputation and two finger-crushing injuries.

Description: This recall involves the Paramount Fitness PL2100 leg curl machine. The single station weight machine is designed to exercise the hamstring muscles. Serial numbers involved in this recall include: PL21-9301-000 through PL21-9510-099. The serial number is printed on the back of the weight stack frame on the lower right. Model number PL2100 is printed on the exercise procedure label on the front of the machine. The Paramount Fitness logo is printed vertically on the frame.

Sold by: Paramount Fitness and fitness specialty dealers nationwide from January 1993 through October 1995 for about $2,400.

Manufactured in: United States

Remedy: Consumers should immediately stop using the fitness machines and contact Paramount Fitness to receive a free repair kit.

Consumer Contact: For additional information, contact Paramount Fitness at (888) 825-8905 between 7:30 a.m. and 4:30 p.m. PT daily, or visit the firm's Web site at www.paramountfitness.com .

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Monday, April 27, 2009

Raw Alfalfa Sprouts Linked to Salmonella Contamination

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time.

The investigation indicates that the problem may be linked to contamination of seeds for alfalfa sprouts. Because suspect lots of seeds may be sold around the country and may account for a large proportion of the alfalfa seeds currently being used by sprout growers, and cases of illness are spread across multiple states, FDA and CDC are issuing this general advisory.

FDA will work with the alfalfa sprout industry to help identify which seeds and alfalfa sprouts are not connected with this contamination, so that this advisory can be changed as quickly as possible.

CDC, FDA and six State and local authorities have associated this outbreak with eating raw alfalfa sprouts. Michigan, Minnesota, Pennsylvania, South Dakota, Utah, and West Virginia have reported 31 cases of illness with the outbreak strain of Salmonella Saintpaul to CDC. Most of those who became ill reported eating raw alfalfa sprouts. Some reported eating raw sprouts at restaurants; others reported purchasing the raw sprouts at the retail level.

The illnesses began in mid-March. Cases are still being reported, and possible cases are in various stages of laboratory testing, so illnesses may appear in other states. No deaths have been reported. The number of infected people may be higher than currently reported because some illnesses have not yet been confirmed with laboratory testing.

The CDC and FDA recommend at all times that persons at high risk for complications, such as the elderly, young children, and those with compromised immune systems, not eat raw sprouts because of the risk of contamination with Salmonella or other bacteria. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses, such as meningitis and bone infections.

Initial investigation results trace the contaminated raw alfalfa sprouts to multiple sprout growers in multiple states. This suggests a potential problem with the seeds used, as well as the possible failure of the sprout growers involved to appropriately and consistently follow the FDA Sprout Guidance issued in 1999 http://www.cfsan.fda.gov/~dms/sprougd1.html. The guidance recommends an effective seed disinfection treatment immediately before the start of sprouting (such as treating seed in 20,000 parts per million Calcium hypochlorite solution with agitation for 15 minutes) and regularly testing the water used for every batch of sprouts for Salmonella and E coli O157:H7 contamination.

This outbreak appears to be an extension of an earlier outbreak in 2009. In February and March, an outbreak of Salmonella Saintpaul infections occurred in Nebraska, South Dakota, Iowa, Kansas, and Minnesota. This outbreak was linked to raw alfalfa sprouts, and the outbreak strain was indistinguishable from that of these recently reported cases. A separate outbreak of Listeria monocytogenes infections was also linked to sprouts in 2009. In the 1990s, a number of outbreaks related to sprouts led FDA to issue its guidance. Experience over the past decade has shown that the likelihood of Salmonella in sprouts can be minimized when recommendations from FDA’s Sprout Guidance are followed.

Preventive controls are very important in the growing of all raw sprouts. FDA reminds sprout growers to be vigilant in their food safety practices and strongly encourages sprout growers to follow the Agency’s Sprout Guidance. Additionally, the United Fresh Produce Association has advised all of its members to follow FDA’s guidance on sprouts. FDA appreciates that the produce industry has reinforced this message and reminds retailers that it is prudent to sell sprouts from growers who follow FDA's recommendations.

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Limited Voluntary Recall of Country Acres® Layer 16 Crumbles Poultry Feed

Land O’Lakes Purina Feed has initiated a limited voluntary recall of a single lot of a Country Acres® poultry feed product, due to the potential for higher than acceptable levels of salt. The presence of salt above acceptable levels can cause serious health issues, and at high levels, potential mortality in poultry.

The product was manufactured at a St. Joseph, Mo., feed plant and was distributed to dealers in a four-state region (northeastern Oklahoma, eastern / central Kansas, western Arkansas, and western Missouri). Dealers have been contacted and asked to hold these products and to notify and retrieve the product from customers. The affected product should be returned to the retail dealer and not used.

The product was distributed only in 50-pound bags and is typically used by small flock owners. The recalled product is identified as follows:

Formula No.	Item No.	Description	Lot No.
6514	0013357	Country Acres® Layer 16 Crumbles	9MAR19STJ3

Lot numbers are printed on the sewing strip of each bag. Lot numbers are formatted as follows: 9MAR19STJ3, 9=Year / MAR= Month / 19=Day of Month / STJ3 = Plant Code.

The recall was initiated after receiving a small number of customer complaints, which involved poultry mortality.

Customers who purchased these products will receive a full refund. For more information on the product recall, contact your local dealer or Customer Service at 1-800-227-8941 between the hours of 8:30 a.m. and 4 p.m. Central time.

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Friday, April 24, 2009

Women's Chenille Robes Recalled by Blair Due to 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: Full Length Women's Chenille Robes

Units: About 162,000

Retailer: Blair LLC, of Warren, Pa.

Hazard: Some robes fail to meet federal flammability requirements and present a risk of serious burns to consumers if they are exposed to an open flame.

Incidents/Injuries: Blair has received three reports of the robes catching on fire, including one report of second-degree burns.

Description: The recall involves the Full Length Women's Chenille Robe with the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. The item number is identified on a label in the garment's neckline. This is a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robe has a full-button front with seven matching button closures, long sleeves with self cuffs, a straight bottom with self hem, and two sideseam pockets. The robe's sewn in label states: "100% Cotton, RN 81700, Made in Pakistan". Robes with other item numbers are not included in the recall.

Sold at: Blair catalogs and Web site, and Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009 from about $20 to $40.

Manufactured in: Pakistan

Remedy: Consumers should stop wearing the garment immediately. Contact Blair LLC for information on returning the robe and to receive a refund or a $50 gift card for Blair merchandise.

Consumer Contact: For more information, call Blair toll-free at (877) 392-7095 between 9 a.m. and 9 p.m. ET Monday through Saturday, visit the firm's Web site at www.blair.com/recall, or contact the firm by e-mail at blairproductrecall@blair.com .

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Thursday, April 23, 2009

Toaster Oven/Broilers Recalled by Haier America Due to Burn or Electrical Shock 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: Toaster Oven/Broilers

Units: About 106,000

Importer: Haier America Trading L.L.C., of New York, N.Y.

Manufacturer: Lun Dar Electric Ind. Ltd., of Taiwan

Hazard: Electrical connections in the toaster oven/broilers can become loose, posing electrical shock and burn hazards.

Incidents/Injuries: Haier America has received two reports of minor burns and one report of a minor electrical shock to consumers, and one report of minor property damage.

Description: This recall involves toaster oven/broilers with model number RTO1400SS. The units are stainless steel and black plastic. "Haier" is printed on the front and the model number is printed on a label on the back of the toaster oven/broilers.

Sold at: Mass merchandisers and specialty retailers nationwide from September 2006 through January 2009 for approximately $20 to $40.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled toaster oven/broilers and contact Haier America to receive a free replacement toaster oven/broiler.

Consumer Contact: For additional information, contact Haier America at (866) 927-4810 anytime, or visit the firm's Web site at www.haieramerica.com

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Alternative Baking Company Conducts Nationwide Recall of Cookies With Chocolate Chips Because of Possible Health Risk: Undeclared Milk

Alternative Baking Company, Inc. of Sacramento, California is conducting a nationwide recall of several types of chocolate chip cookies with code dates of 015 through 036 stamped on the fold of the cellophane package in black ink. The chips appear to contain milk and have caused reactions in a few children who are highly allergic to milk according to phone calls from parents of the affected children. 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 cookies are wrapped and sold individually in retail stores and on our web site. Listed in the chart are the cookies with the pertinent information for identifying the recalled cookies.

Product	UPC #	Date Code (Stamped on fold)	Weight	Unit
Colossal Chocolate Chip	703741 000178	015 through 036	4.25 oz	Each
Explosive Espresso Chocolate Chip	703741 001014	015 through 036	4.25 oz	Each
Peanut Butter Chocolate Chip	703741 000635	015 through 036	4.25 oz	Each
Double Chocolate Decadence	703741 000628	015 through 036	4.25 oz	Each
Mac the Chip	703741 000352	015 through 036	4.25 oz	Each

Alternative Baking Company has since found a new company which guarantees their chocolate chips are: 100% Vegan, 100% Dairy Free and Processed on Dedicated Equipment.

Consumers are to return any of these products with the codes of 015 through 036 to the store where purchased to exchange them or to received a full refund. Consumers may also mail their cookies with the proper codes to Alternative Baking Co., 3914 Kristi Court, Sacramento, CA 95827. Our hours are Monday through Friday 8am to 4pm (PT), phone number is (888) 488-9725.

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Wednesday, April 22, 2009

Stop & Shop Removes Simply Enjoy Brand Cookies

Following notification from its manufacturer, The Stop & Shop Supermarket Company today removed from stores Simply Enjoy Pina Colada White Chocolate Gourmet Cookies. The product contains pecans, an undeclared allergen.

The products has UPC# 6 8826705538 and comes in a 7 oz. package.

Stop & Shop has not received any reports of illness or injuries associates with the consumption of this product.

Customers who have purchased the product should discard any unused portions or bring their purchase receipt to any Stop & Shop supermarket for a full refund. Customers looking for additional information are encouraged to call Stop & Shop’s corporate brands consumer line at 1-877-846-9949, Monday through Friday from 9am – 4pm.

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