FDA Sets Defective Products’ Alert

MANILA, Philippines — The Food and Drug Administration (FDA) on Friday set guidelines on the transmission of information between FDA and other government agencies relating to rapid alerts on the recall and withdrawal of health products intended for humans and animals, but are defective or are fake.
The FDA said it will have a written procedure in the issuance, receipt and handling of notifications for defective products, batch recalls and other rapid alerts.
It said the rapid alert system will transmit “only those alerts whose urgency and seriousness cannot permit any delay in transmission.”
An assessment will be made to determine the seriousness of the defect, its potential harm to the patient, animals, consumers, operators and the environment.
The FDA has established three classes of classification in the recall of defective health products.
Class I defects are those which are potentially life threatening. Under this, a rapid alert notice will be sent. These include wrong products whose labels and contents are different; correct product but wrong strength; microbial contamination of sterile injectable or ophthalmic product; chemical contamination with serious medical consequences; mix-up of some products with more than one container involved; and wrong active ingredient in a multi-component product with serious medical consequences.
Those that can cause illness or mistreatment and outside the scope of Class I are classified as Class II defects. These defects are mislabeling; missing or incorrect information on the insert or leaflet; microbial contamination of non-injectable, non-ophtalmic sterile product with medical consequences; chemical and physical contamination; mix-up of products in containers; non-compliance with specification; and faulty closure with serious medical consequences.
Class III defects are those that may not pose significant hazard to health and withdrawal of the product is done for a different reason. These include faulty packaging like wrong or missing batch number of expiry date; faulty closure; and contamination like microbial spoilage or dirt.
In addition, the FDA said the rapid alert system may also be used to notify authorities of the recall of products or an embargo on the distribution of products following the suspension or withdrawal of a manufacturing, importation or wholesale authorization.
Under the system, the FDA will issue the alert if the product is first identified in the Philippines. It will lead in the investigation of the defect and issue appropriate alert.
All alerts will be sent via email.
FDA Sets Defective Products’ Alert | The Manila Bulletin Newspaper Online

H&M Recalls Children's Water Bottle Due to Choking Hazard, Sold Exclusively at H&M Stores

Name of Product: Children's Water Bottle
Units: About 2,900
Importer: H&M Hennes & Mauritz, New York, N.Y.
Hazard: The water bottle's spout can break off, posing a choking hazard to children.
Incidents/Injuries: H&M has received one report of an incident in England of the water bottle spout breaking off in a child's mouth as the child was drinking from the bottle. No injuries have been reported.
Description: The 16 oz. water bottles are pink plastic with a crackle design or blue plastic. The bottles have flip-top lids in coordinated pink and blue colors. "H&M Sweden" and "www.hm.com" are embossed on the bottom of the bottle. The recalled products were manufactured in June 2012. The water bottle contains the manufacture date in an embossed date clock on the bottom of the bottle. The inner circle on the clock contains the number 12 with an arrow between the two numbers. The arrow points at the number 6 in an outer circle of numbers.
Sold exclusively at: H&M stores with children's departments nationwide from July 2012 through August 2012 for about $5.
Manufactured in: Italy
Remedy: Consumers should immediately stop using the water bottle and return it to H&M for a full refund.
Consumer Contact: For additional information, contact H&M toll-free at (855) 466-7467 or visit the firm's recall page on its website at www.hm.com

H&M Recalls Children's Water Bottle Due to Choking Hazard, Sold Exclusively at H&M Stores

Bluestem Brands Recalls Range Rider Ride-on Toy Cars Due to Fire and Burn Hazards

Name of Product: Range Rider Ride-On Toy Cars
Units: About 4,700
Importer: Bluestem Brands, Inc., of Eden Prairie, Minn., owner of Fingerhut and Gettington
Hazard: The battery can overheat, smoke, melt and catch on fire, posing fire and burn hazards to consumers.
Incidents/Injuries: Bluestem has received nine reports of incidents in which batteries smoked or caught on fire and melted the battery�s connections or scorched the plastic in the ride-on car. No injuries have been reported.
Description: This recall involves battery-powered Range Rider ride-on toy cars with an off-road vehicle body style and plastic tires. The ride-on cars were sold in pink and tan colors. The recalled Range Riders can be identified by their product code and model number. The model number is on the back of the seat of the ride-on toy car. The product code does not appear on the ride-on toy cars, but can be found on the product carton. The recalled models include:

Model #	Product Code	Product
90407B	NI374	Tan Range Rider
90407G	NU640	Pink Range Rider

Sold at: Fingerhut catalogs and online at Fingerhut.com and Gettington.com from September 2010 through May 2012 for between $200 and $230.
Manufactured in: China
Remedy: Consumers should immediately stop using the recalled ride-on toy cars and remove the battery and contact Bluestem for a full refund of the purchase price plus reimbursement for shipping and handling. The firm is directly contacting those who purchased the recalled ride-on toy cars.
Consumer Contact: For more information, contact Bluestem toll-free at (866) 931-5417 between 8 a.m. and 5 p.m. CT Monday through Friday, or visit the firm's websites at www.fingerhut.com or www.gettington.com and click on Product Recall.

   

Bluestem Brands Recalls Range Rider Ride-on Toy Cars Due to Fire and Burn Hazards

Mr. Coffee Single Cup Brewers Recalled by JCS Due to Burn Hazard

Name of Product: Mr. Coffee® Single Cup Brewing System
Units: 520,000 in the United States and 80,700 in Canada
Importer: Sunbeam Products Inc. d/b/a Jarden Consumer Solutions ("JCS"), of Boca Raton, Fla.
Hazard: A build-up of steam in the water reservoir can force the brewing chamber open and expel hot coffee grounds and water, posing a burn hazard.
Incidents/Injuries: JCS has received 164 reports of the brewing chamber opening due to steam pressure, including approximately 59 reports in the U.S. and two in Canada of burn injuries to consumers' face, upper torso and hands.
Description: The recalled coffeemaker comes in black with silver, red or white trim. It stands about 11 inches tall and has a Brew Now /Off button and a removable drip tray. The water tank is located on top of the unit towards the back. The model number is printed on the bottom of the brewer. Recalled model numbers are:

BVMC-KG1	BVMC-KG1A-001	BVMC-KG1-WM-001
BVMC-KG1-001	BVMC-KG1-BEA	BVMC-KG1R-001
BVMC-KG1-044	BVMC-KG1BP-PAL	BVMC-KG1R-006
BVMC-KG1A	BVMC-KG1-WM	BVMC-KG1W-001

Sold by: Mass merchandisers nationwide, including Bed Bath & Beyond, Brandsmart, JC Penney, Kmart, Lowe's, Target and Walmart, and online at www.mrcoffee.com from September 2010 through August 2012 for between $60 and $80.
Manufactured in: China
Remedy: Consumers should immediately stop using the recalled coffee brewer and contact JCS to receive instructions on how to obtain a free replacement unit.
Consumer Contact: For additional information, contact JCS at (800) 993-8609 anytime, or visit the firm's website at www.mrcoffeerecall.com
Note: Health Canada's press release is available at http://cpsr-rspc.hc-sc.gc.ca/PR-RP/recall-retrait-eng.jsp?re_id=1674

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Mr. Coffee Single Cup Brewers Recalled by JCS Due to Burn Hazard

Summer Infant Recalls to Repair Baby Bathers Due to Fall and Head Injury Hazard

Name of Product: Mother�s Touch/Deluxe Baby Bathers
Units: About 2 million in the United States and an additional 65,000 in Canada
Manufacturer: Summer Infant Inc., of Woonsocket, R.I.
Hazard: When the bather is lifted and/or carried with an infant in it, its folding wire frame can suddenly disengage from the side hinge, dropping the baby out of the bather, posing a fall hazard and a risk of serious head injury to infants.
Incidents/Injuries: CPSC and Summer Infant have received seven reports of incidents in the U.S., including five reports of infants suffering head injuries from falls from the bathers. Four children between two weeks and two months old received skull fractures, including one that required intensive care for bleeding on the brain. The fifth child received a bump to the head requiring emergency room treatment.
Description: This recall involves Summer Infant baby bathers with a small, nearly square blue or pink plastic base measuring about 13 � inches long by 12 � inches wide and with the following model numbers listed below. Model numbers are located either on the side of the baby bather near the warning label or on the front near the wash instructions. Some units have multiple model numbers. Model numbers with an additional letter at the end of the model number are also included in this recall.

Recalled Summer Infant Baby Bathers
Model Numbers
08020, 08050, 08054, 08070, 08401, 08409, 08404, 08405, 08650, 08655, 08659, 08754, 08940, 08944
18004, 18040, 18049, 18050, 18120, 18125, 18129, 18254, 18360, 18375, 18379, 18390, 18394, 18440, 18445, 18449, 18470, 18475, 18479
38510, 38515, 38750, 38755

The bathers have adjustable side hinges with five rivets each and a white wire frame with a mesh fabric sling seat and two or three positions for the seats. Some also have a head support cushion. The fabric seat comes in various colors including white, blue, green, yellow and orange with fish, turtles, butterflies, frogs, flowers and duck patterns. Bathers manufactured since July 2007 include the warning �Never lift or carry the bather with infant in it.�
Sold at: Mass merchandise stores nationwide and on the Web from September 2004 through November 2011 for between $15 and $30.
Manufactured in: China
Remedy: Consumers should immediately stop using the bathers and contact Summer Infant for a free repair kit that includes a locking strap and instructions. Note: Even with the new locking strap installed, the baby bather product should never be used to lift and carry an infant.
Consumer Contact: For additional information, contact Summer Infant 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/batherrepairkit. Do not return to stores as the retailers will not have the repair kit
Note: Health Canada's press release is available at http://cpsr-rspc.hc-sc.gc.ca/PR-RP/recall-retrait-eng.jsp?re_id=1675

Side hinges have five rivets






Bathers manufactured since July 2007 include the warning �Never lift or carry the bather with infant in it.�

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Summer Infant Recalls to Repair Baby Bathers Due to Fall and Head Injury Hazard

CareBears Pacifier Recalled by IDM Group Due to Choking Hazard

Name of product: CareBears™ Pacifiers
Units: About 119,000
Importer: IDM Group LLC, of New York
Manufacturer: Yi Wu Jiangyi Plastic Co., of China
Hazard: The pacifiers fail to meet federal safety standards. The nipples can separate from the base, posing a choking hazard to young children.
Incidents/Injuries: None reported.
Description: The pacifiers and the clip attachment have CareBear figures and a "TCFC" copyright mark on them. The nipple is made of silicone.
Sold at: Various discount and dollar stores, Walmart Puerto Rico, children's apparel stores and Consolidated Stores nationwide from October 2009 through June 2012 for about $1.
Manufactured in: China
Remedy: Consumers should immediately take the recalled pacifiers away from infants and contact IDM Group LLC for instructions on returning the product for a full refund.
Consumer Contact: For additional information, contact IDM collect at (212) 686-5221 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the company�s recall web site at www.pacifierrecall.net

CareBears Pacifier Recalled by IDM Group Due to Choking Hazard

Energizer Recalls Night Lights Due to Burn Hazard; Sold Exclusively at Target

Name of product: Energizer Rotating Night Lights
Units: About 260,000
Importer: Energizer, of St. Louis, Mo.
Manufacturer: Ningbo Sun-alps Industry Develop Co. Ltd, of China
Hazard: The night lights can overheat and smoke, posing a burn hazard to consumers.
Incidents/Injuries: Energizer has received nine reports of the night lights overheating, including three reports of minor property damage. No injuries have been reported.
Description: This recall involves Energizer LED rotating night lights. The night lights are white and have an LED light inside an adjustable dome on top. The night lights measure about 2 inches wide by 2 � inches long. Model number �ENLPLROT� and date codes between 0110 (for January 2010) through 0111 (for January 2011) are included in this recall. The model number is stamped onto the side of the night light. The date code is stamped in a circle on the back of the night light. The arrow points to the month of production (i.e. 12 = December) and the number positioned on either side of the arrow represents the year (i.e. �10� = 2010).
Sold exclusively at: Target stores nationwide from February 2010 through July 2012 for about $6.
Manufactured in: China
Remedy: Consumers should immediately stop using and unplug the recalled night lights. Contact Energizer for instructions on returning the night lights for a $7 coupon towards the purchase of an Energizer product.
Consumer Contact: For additional information, contact Energizer at (800) 383-7323 between 8 a.m. and 6 p.m. CT Monday through Friday, or visit the firm�s website at www.energizer.com

Energizer Recalls Night Lights Due to Burn Hazard; Sold Exclusively at Target

LG Electronics and Sears Recall Gas Dryers For Repair Due to Fire Hazard

Name of Product: LG Electronics and Kenmore Elite® Gas Dryers
Units: About 21,000
Manufacturer: LG Electronics, Inc., of South Korea
Hazard: The gas valve in the recalled dryers can fail to shut off properly, continuing to heat the dryer and its contents after the drying cycle is complete. High temperatures inside and on the exterior surface of the dryers can scorch the drum, as well as burn or damage the dryer contents, posing a risk of burn, fire and smoke inhalation.
Incidents/Injuries: LG Electronics and Sears have received 141 consumer complaints about dryers continuing to heat after the drying cycle is complete. There were three reports of minor burns to hands or arms. Burnt or scorched clothing was reported in more than 50 incidents.
Description: LG Electronics and Sears' Kenmore Elite brand gas dryers come in the following colors: LG models in white; Kenmore Elite® in red, white and ginger (gold). Model and serial numbers can be found on a label fixed to the front of the dryer above the opened door, which can be viewed only when the dryer door is open. To confirm if your dryer is part of this recall, identify both model and serial numbers, since not all dryers with the listed models are recalled.

Brand	Model Numbers	Serial Numbers
LG Electronics	DLG0452W DLG1320W DLG2051W	001KW**00001 through 001KW**00090 911KW**00271 through 911KW**00630 001KW**00001 through 001KW**01518 002KW**00001 through 002KW**00450 911KW**00184 through 911KW**00561 912KW**00001 through 912KW**00090 001KW**00001 through 001KW**03150 002KW**00001 through 002KW**01620 911KW**00061 through 911KW**01860 912KW**00001 through 912KW**02520
Kenmore Elite®	796.90512900 796.90518900 796.91022900 796.91028900 796.91029900 796.92192900 796.92198900 796.92199900	001KW**00001~001KW**00180 911KW**00091~911KW**00450 912KW**00001~912KW**00450 001KW**00001~001KW**00540 002KW**00001~002KW**00090 911KW**00001~911KW**00450 912KW**00001~912KW**00270 001KW**00001~001KW**00360 002KW**00001~002KW**00042 911KW**00001~911KW**00315 912KW**00001~912KW**00540 001KW**00001~001KW**00270 002KW**00001~002KW**00090 911KW**00001~911KW**00171 912KW**00001~912KW**00539 001KW**00001~001KW**00270 911KW**00271~911KW**00402 912KW**00001~912KW**00450 001KW**00001~001KW**00270 911KW**00181~911KW**00542 912KW**00001~912KW**00270 001KW**00001~001KW**00360 911KW**00001~911KW**00440 912KW**00001~912KW**00270 001KW**00001~001KW**00084 911KW**00091~911KW**00361 912KW**00001~912KW**00270

Sold by: LG Electronics brand gas dryers were sold by various appliance stores, including Sears, nationwide from November 2009 through August 2010. Kenmore Elite® brand gas dryers were sold at Sears stores nationwide from November 2009 through August 2010. The approximate retail cost for the recalled dryers was between $650 and $1500 for these various models.
Manufactured in: South Korea
Remedy: Consumers should turn off the gas supply and stop using the dryers until repaired. LG brand owners who purchased their dryer at retailers other than Sears should contact LG customer service to arrange for a free gas valve replacement. Customers who purchased Kenmore or LG brand dryers from Sears should contact Sears' customer service to schedule a free repair to replace the gas valve. Some consumers have already been notified and have received the repair service.
ATTENTION: Dryers that have a colored sticker on the back, top, or a colored sticker or a plus sign ("+") on the back, bottom, near the gas valve assembly, have already been repaired. If accessible, consumers can check for these stickers or sign. If not accessible, contact LG or Sears as detailed below.
LG Consumer Contact: For additional information about the recall and to schedule a repair, contact LG toll free at (866) 223-5355 between 8 a.m. and 7 p.m. CT Monday through Friday, and between 8 a.m. and 2 p.m. CT on Saturday, or visit the firm's website at www.lg.com/us and click on Public Notices.
Sears Consumer Contact: For additional information and to schedule a repair, contact Sears toll-free at (888) 375-9741 between 7 a.m. and 9 p.m. CT Monday through Friday, and between 7:00 A.M. and 6:00 P.M. Saturday, or visit the firm's website at www.sears.com and click on Product Recalls under Customer Service.

LG Dryers
DLG0452W	DLG1320W	DLG2051W

Sears Kenmore Elite Dryers
796.90512900	796.90518900	796.91022900
796.91028900	796.91029900	796.92192900

796.92198900		796.91029900

Both LG and Kenmore Elite Dryers' Model and Serial Numbers are in the location shown in the diagram below:

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LG Electronics and Sears Recall Gas Dryers For Repair Due to Fire Hazard

Trail mix sold at BI-LO recalled

Trail mix sold at BI-LO is being recalled because it is not properly labeled, which could be a problem for people with food allergies.
BI-LO announced an immediate voluntary recall on Southern Home Cranberry Nut Antioxidant Blend Trail Mix sold in the 16 oz. bag with a universal bar code of 0788003039 and a best-by date of March 12, 2013.

 The product is being recalled in the states of Georgia, North Carolina, South Carolina and Tennessee due to a potential, undeclared presence of soy lecithin, which is a processed soy product. The processing reduces the content of allergenic proteins; however, persons with a severe soy allergy may still have serious reactions to the reduced protein found in the soy lecithin.
The recall is being initiated out of an abundance of caution for customer safety, though the company has received no reports of illness associated with product consumption. The issue was reported to BI-LO by a customer.
"We encourage consumers in possession of the recalled item to immediately discard the product or bring it back to their local BI-LO,” said Allen Reavis, BI-LO’s vice president of grocery. “As part of the company’s satisfaction guarantee, customers who have purchased the product may visit their neighborhood store to request a full refund.”
To receive the refund, individuals must present proof of purchase through a receipt or the product packaging label.

Customers with questions about the recalled product may contact BI-LO’s consumer relations department at 1-800-862-9293. Hours of operation are Monday-Friday from 8 a.m. – 6 p.m., and Saturday from 8 a.m. – 5 p.m. ET.

Baby Seats Recalled for Repair by Bumbo International Due to Fall Hazard

Units: About 4 million in the U.S. Note: In October 2007, 1 million Bumbo seats were voluntarily recalled to provide additional warnings against use on raised surfaces.
Manufacturer: Bumbo International Trust, of South Africa
Hazard: Babies can maneuver out of or fall from the Bumbo seat, posing a risk of serious injuries.
Incidents/Injuries: CPSC and Bumbo International know of at least 50 incidents after the October 2007 voluntary recall in which babies fell from a Bumbo seat while it was being used on a raised surface. Nineteen of those incidents included reports of skull fractures. CPSC and Bumbo International are aware of an additional 34 post-recall reports of infants who fell out or maneuvered out of a Bumbo seat used on the floor or at an unknown elevation, resulting in injury. Two of these incidents involved reports of skull fractures, while others reported bumps, bruises and other minor injuries.
Description: The bottom of the Bumbo seat is round and flat with a diameter of about 15 inches. It is constructed of a single piece of molded foam and comes in various colors. The seat has leg holes and the seat back wraps completely around the child. On the front of the seat in raised lettering is the word "Bumbo" with the image of an elephant on top. The bottom of the seat has the following words: "Manufactured by Bumbo South Africa Material: Polyurethane World Patent No. PCT: ZA/1999/00030." The back of the seat has several warnings and seats manufactured since 2008 have an additional label on the front of the seat warning against use on raised surfaces.
Sold by: Sears, Target, Toys R Us (including Babies R Us), USA Babies, Walmart, and various other toy and children's stores nationwide, and various online sellers, from August 2003 through August 2012 for between $30 and $50.
Manufactured in: South Africa
Remedy: Consumers should immediately stop using the product until they order and install a free repair kit, which includes: a restraint belt with a warning label, installation instructions, safe use instructions and a new warning sticker. The belt should always be used when a child is placed in the seat. Even with the belt, the seat should never be used on any raised surface. Consumers should also immediately stop using Bumbo seat covers that interfere with the installation and use of the belt. A video demonstrating proper installation of the restraint belt and proper use of the Bumbo seat are available at www.BumboUSA.com
Consumer Contact: Order the free repair kit by visiting www.recall.BumboUSA.com or calling (866) 898-4999 between 8 a.m. and 5 p.m. CT Monday through Thursday and between 8 a.m. and 12:30 p.m. CT on Friday. Do not return the Bumbo seat to retailers as they will not be able to provide the repair kit.

Bumbo seat with restraint belt repair (side view and top view)

Baby Seats Recalled for Repair by Bumbo International Due to Fall Hazard