Rechargeable Batteries in Video Baby Monitors Recalled to Replace by Summer Infant Due to Burn Hazard; Sold Exclusively at Babies R Us

/PRNewswire/ -- 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of product: Rechargeable batteries sold with certain Slim and Secure™ Video Monitors
Units: About 58,000

Importer: Summer Infant, of Woonsocket, R.I.

Manufacturer of Batteries: MP and BK, of China

Hazard: The battery in the handheld video monitor can overheat and rupture, posing a burn hazard to consumers.

Incidents/Injuries: Summer Infant has received five reports of ruptured batteries, including three incidents of minor property damage. No injuries were reported.

Description: The recall involves Summer Infant Slim and Secure handheld color video monitors with unmarked, MP and BK rechargeable batteries. The Video Monitor is sold in either silver and white, model #02800; or pink and white, model #02805. It has receiver and camera components. The receiver is approximately 4 1/4" tall and 2 1/2" wide with a 2.5" LCD screen with the "Summer" logo printed in white on the bottom front. The camera is silver and white. Both the video monitor and receiver components come with A/C adapters but only the receiver unit contains a rechargeable battery. The batteries are unmarked or marked with letters MP or BK on the lower right corner of the battery. Batteries that are marked TCL are not included in this recall.

Sold at: Exclusively at Babies R Us from September 2009 to May 2010 for about $200.

Manufactured in: China

Remedy: Consumers should immediately stop using the video baby monitors with the recalled batteries and contact Summer Infant to receive a postage paid envelope to return the defective battery in exchange for a free replacement battery. The monitor can continue to be used on AC power with power cord.

Consumer Contact: For additional information, contact Summer Infant between 8 a.m. and 5 p.m. ET Monday through Friday at (800) 426-8627, or visit the firm's website at www.summerinfant.com.

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Two Strangulation Deaths Prompt Summer Infant to Recall Video Baby Monitors with Cords; Firm to Provide New On-Product Label & Instructions

/PRNewswire/ -- The U.S. Consumer Product Safety Commission (CPSC), in cooperation with Summer Infant Inc., of Woonsocket, R.I., is announcing the voluntary recall to provide new on-product label and instructions for about 1.7 million video baby monitors with electrical cords. The cords can present a strangulation hazard to infants and toddlers if placed too close to a crib. Because of this serious strangulation risk, parents and caregivers should never place these and other corded cameras within three feet of a crib.

Over the past year, CPSC and the firm have received reports of two strangulation deaths of infants with the electrical cords of Summer Infant video baby monitors. In March 2010, a 10-month-old girl from Washington, D.C. strangled in her crib in the electrical cord of a Summer Infant video monitor. The monitor camera had been placed on top of the crib rail.

In November 2010, CPSC received a report of a six-month-old boy from Conway, S.C., who strangled in the electrical cord of a baby monitor placed on the changing table attached to the crib. In January 2011, CPSC learned the product involved was a Summer Infant video baby monitor.

CPSC and the firm are also aware of a near strangulation incident in which a 20-month-old boy from Pittsburg, Pa. was found in his crib with the camera cord wrapped around his neck. The Summer Infant monitor camera was mounted on the wall, but the child was still able to reach the cord. He was freed from the cord without serious injury.

Summer Infant has initiated a campaign to provide new on-product labels for electric cords and instructions to consumers with the recalled video monitors distributed between January 2003 and February 2011. The baby monitors were sold at major retailers, mass merchandisers, and juvenile products stores nationwide for between $60 and $300. They were sold in more than 40 different models, including handheld, digital, and color video monitors. All video monitors include both the camera (placed in the baby's room) and the hand held device (some models have 2 hand-held devices) which enable the caregiver to see and/or hear the baby from a specific distance. The brand "Summer" is found on the product.

The product was manufactured in China.

CPSC and Summer Infant urge parents to immediately check the location of the video monitors, including cameras mounted on the wall, and all electric cords to make sure the cords are out of arm's reach of their child. Consumers should contact Summer Infant toll-free at (800) 426-8627 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the firm's website at www.summerinfant.com/Home/Product-Recall.aspx to receive a new permanent electric cord warning label about the strangulation risk and revised instructions about how to safely mount camera and keep cords out of child's reach.

In October 2010, CPSC issued a safety alert warning consumers that there had been six reports of strangulation in baby monitor cords since 2004. Since that alert the number of death reports has risen to seven. CPSC has revised the safety alert Infants Can Strangle in Baby Monitor Cords.

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FDA announces recall of Abbott glucose test strips

The U.S. Food and Drug Administration today (December 22) announced the agency is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips marketed under the following brand names:

* Precision Xceed Pro;
* Precision Xtra;
* Medisense Optium;
* Optium;
* OptiumEZ; and
* ReliOn Ultima

These strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The blood glucose monitoring systems are not affected by this recall.

The recall pertains to certain lots of these test strips distributed in the United States and Puerto Rico. Other Abbott Diabetes Care products are not affected by the recall.

The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient’s health.

The recall is related to the test strips’ inability to absorb enough blood for monitoring. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result.

The test strips were manufactured between January and September 2010 and are sold both in retail and online settings directly to consumers, but are also used in health care facilities.

The FDA has provided recommendations for consumers and health care professionals below that explain how to determine whether a particular lot is affected, how to order free replacement strips and how to use recalled strips to reduce the likelihood a false result.

“Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health,” said Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostics in FDA’s Center for Devices and Radiological Health. “FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.”

To determine if you have product being recalled:

* Call Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Spanish) to speak with a customer service representative.
* Visit www.precisionoptiuminfo.com to look up test strip lot numbers.

Consumers should report serious adverse events (side effects) with the device to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.

* Online
* Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
* Fax: 800-FDA-0178
* Phone: 800-332-1088

Recommendations for Consumers Who Purchased the Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Blood Glucose Test Strips

For consumers who purchased test strips in retail stories or online, FDA recommends:

* Calling Abbott for a replacement of the affected strips. Abbott will send you unaffected Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Test Strips at no charge.
* While waiting for the replacement strips to arrive, use an alternate method to measure blood glucose (such as a different test system) or purchase at least two weeks worth of new, unaffected strips while waiting for replacement strips.
* If you purchase Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Test Strips in a store or online, check to be sure these are from unaffected lots. Ask a pharmacist to help you.
* If the only test strips available to you are from affected lots, do not stop testing your blood glucose. But do take the following two precautions to reduce the chance of erroneous reading:

Precaution 1: Check the amount of time it takes for your blood glucose meter to start the “countdown” after you first apply blood to the test strip. Start timing immediately after blood first makes contact with the test strip. If your meter takes longer than five (5) seconds to start the countdown that test strip is defective and the result should not be used.

Check the time for each test strip you use because all of the strips in a package may not be affected to the same degree.

Precaution 2: If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider.

Pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).

* Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
* Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure. If you are unable to obtain unaffected strips, you should contact your health care provider for advice on how to treat these symptoms before they occur.

Recommendations for Health care Professionals using Precision Xceed Pro Blood Glucose System

If you have affected strips, FDA recommends the following:

* If available, immediately switch to using test strips from unaffected lots.
* If your facility does not have any test strips from unaffected lots, and you have immediate access to an alternate Point of Care blood glucose testing system within your healthcare facility, discontinue use of the Precision Xceed Pro Blood Glucose Test System and use the alternate method until you can obtain unaffected Precision Xceed Pro Blood Glucose Test Strip lots.
* If your facility does not have test strips from unaffected lots, and you do NOT have immediate access to an alternate Point of Care blood glucose testing system, FDA recommends the following procedures:

1. Verify any critical glucose test results (e.g., test results that may be used to adjust insulin therapy in vulnerable patient populations) generated on the Precision Xceed Pro Blood Glucose Test System using a central laboratory blood glucose method. Medical judgment should be applied when deciding whether to act on results prior to verification.
2. Verify any Precision Xceed Pro Blood Glucose Test System results that do not match a patient’s symptoms, or seem unexpected for the patient’s clinical status, using a central laboratory blood glucose method.
3. When using the Precision Xceed Pro Blood Glucose Test System, take precautions to reduce the chance of an erroneous reading. Limited evidence suggests that results may be accurate using strips from affected lots if fill time does not exceed five seconds. Monitor the amount of time it takes for the Precision Xceed Blood Glucose Meter to start the “countdown” after blood is first applied to the test strip. If the amount of time exceeds five (5) seconds, discard that test strip immediately because the blood glucose result may be erroneously low. In addition, if this occurs:
i. Note the specific lot number of that test strip;
ii. Notify Abbott Diabetes Care to report the observed problem with that lot by calling 1-877-529-7185;
iii. Make sure to check fill time on each individual strip during use and do not assume if one strip in a package/lot appears to be unaffected, that all strips in that package/lot are unaffected.

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Circus World Recalls Wireless Video Baby Monitors Due to Overheating Hazard

/PRNewswire/ -- 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Levana Wireless Video Baby Monitors
Units: About 800

Distributor: Circus World Displays Limited (CWD), of Niagara Falls, Ontario, Canada.

Hazard: Wiring in the baby monitor camera can overheat and emit smoke, posing a burn hazard to consumers.

Incidents/Injuries: Circus World Displays has received two reports of the camera portion of the monitors overheating and smoking. No injuries have been reported.

Description: This recall involves Levana wireless baby monitors with model number LV-TW300. The receiver front is white and green with six round buttons and the printed word "Levana". It is 7 inches tall and includes a stand/base. The camera is all white, about 5 inches tall and is attached to a 3 1/2 inch long white base. The camera can rotate and swivel in various directions. The camera and receiver each has its own A/C adapters.

Sold at: BB Buggy &Health and Safety stores nationwide and on the Internet between February 2010 and May 2010 for about $200.

Manufactured in: China

Remedy: Consumers should immediately stop using and return the baby monitor directly to CWD for a refund or replacement with a different model. When returning, please include the entire product, your complete name, mailing address and phone number in the package and mail to Circus World Displays Ltd, Attention: Adam Crysler, Dealer Returns Specialist, 60 Industrial Parkway Suite Z64, Cheektowaga, NY 14227

Consumer Contact: For additional information, contact Circus World Displays toll-free at (866) 946-7828 between 8 a.m. and 5 p.m. ET Monday through Friday, by e-mail at support@svat.com or on the firm's website at www.mylevana.com.

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