Posts Tagged ‘recall’
Product Liability Warnings For Blender and Antinausea Drug
Consumers want to take note of two recent product safety announcements, one involving a popular blender sold at Target stores and another concerning an antinausea drug which has been linked to a potentially fatal heart rhythm.
Defective Blender: On Sept. 15, 2011, Target Corp. and manufacturer Select Brands, Inc. announced the recall of the Chefmate(r) 6-Speed Blender. Target and the Consumer Product Safety Commission have received 11 reports of the blender’s blades separating from the pitcher. In seven cases, consumers using the recalled Target product suffered serious lacerations and injuries to fingers and hands.
Approximately 304,000 defective blenders were sold at Target stores in Massachusetts and nationwide between September 2007 and Febrauary 2011. The blenders have the model number BL-10.
Consumers are advised to return the recalled product to Target stores for a full refund or contact the store’s guest relations department at 800-440-0680.
Drug Danger: Also on Sept. 15, the Food and Drug Administration (FDA) announced clinicians should avoid prescribing the drug ondansetron to patients with congenital long QT syndrome, which is a syndrome affecting the electrical functions of the heart. These patients are at risk for developing an abnormal and potentially fatal heart rhythm called torsades de pointes.
Ondansetron is widely known as Zofran, manufactured by GlasxoSmithKline. It is prescribed to prevent nausea and vomiting experienced during cancer chemotherapy, radiation therapy and surgery.
The FDA is revising the drug’s label to warn about the risk for the heart arrythmia. It will include recommendations for electrocardiogram monitoring for patients with electrolyte abnormalities, congestive heart failure and bradyarrhythmias and for patients taking other medications.
The FDA is also requiring GlaxoSmithKline to conduct a study to determine the degree to which ondansetron may trigger the complications.
The Massachusetts product liability lawyers at Breakstone, White & Gluck are experienced in representing individuals injured by defective products, including defective medical devices and improperly used medications. If you have been injured, contact us toll-free at 800-379-1244 for a free legal consultation. You can also use our contact form.
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Surgical Mesh To Be Reviewed By FDA Sept. 8-9
Following thousands of reports about serious injuries among women, a Food and Drug Administration (FDA) panel will begin examining the safety of surgical mesh on Sept. 8 and 9.
Surgical mesh is implanted during transvaginal mesh surgery, the treatment for Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The procedure is performed to repair weak or stretched vaginal tissue, often after childbirth.
The panel’s review comes almost two months after the FDA’s July 13 public safety advisory on surgical mesh and as special interests step into the debate about a possible surgical mesh recall.
In the July 13 advisory, the FDA said transvaginal POP repair with mesh has no advantage over traditional non-mesh repair. The FDA’s finding was based on a review of scientific literature published between 2006 and 2011.
Between 2005 and 2010, more than 3,800 women had reported complications and injuries following transvaginal mesh surgery, according to the FDA.
The most prevalent complaint was mesh erosion within the body, but other injuries included bleeding, pain during sexual intercourse, organ perforation, vaginal scarring, muscular and emotional problems. Remedies include corrective surgery, hospitalization and intensive follow-up medical treatment.
On August 25, 2011, Public Citizen, a Washington D.C.-based consumer advocacy group, called for a recall of all non-absorbable synthetic material used in transvaginal mesh surgery. It also wants a reclassification of the approval process for new surgical mesh products.
The same day, a coalition of 600 pelvic surgeons submitted the FDA a letter challenging its findings about the risk for complications during transvaginal mesh surgery. The letter was obtained by the CommonHealth medical website. Among their challenges, the surgeons argued mesh erosion is not a major complication.
In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, including 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA.
Nine companies manufacture transvaginal mesh products, including Boston Scientific and Johnson & Johnson. Bloomberg News reported one recommendation from the FDA staff administration would require the manufacturers to submit additional safety data to regulators.
The FDA cleared 85 mesh devices to treat pelvic organ prolapse from 1992 to 2010.
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Advocacy Group Calls for Transvaginal Mesh Recall
Several weeks after the Food and Drug Administration (FDA) issued a public notice about the dangers of transvaginal mesh surgery, a consumer advocacy group is calling for the recall of all surgical mesh products used in the procedure.
Public Citizen of Washington D.C. petitioned the FDA on August 25, calling for the recall of all surgical mesh products made of non-absorbable synthetic material used in transvaginal mesh surgery. This type of mesh is used during transvaginal surgery to repair pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). POP occurs when organs bulge into the vaginal and bladder areas. SUI is a loss of bladder control.
In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, including 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA.
Public Citizen is further calling for a ban on marketing all surgical mesh products made for transvaginal mesh surgery and for any future versions of the mesh to be classified as Class III medical devices. This would provide stricter approval requirements.
Nine companies manufacture transvaginal mesh products, including Boston Scientific, Johnson & Johnson, C.R. Bard, Tyco Covidian and AMS.
On July 13, the FDA issued an urgent public notice on the medical devices after receiving thousands of reports about painful complications. The notice updated a public health notification issued on October 20, 2008.
The agency reported it had received over 2,800 reports of complications between January 2008 and December 2010. It said serious complications associated with surgical mesh for transvaginal repair of POP are not rare. It advised healthcare providers that in most cases, POP can be treated successfully without mesh surgery.
Finally, the FDA said mesh surgery should only be chosen after health care providers and patients carefully weigh out the risks and benefits over other options.
In September, the FDA will convene a panel to make recommendations for transvaginal mesh surgery.
Complications from transvaginal mesh surgery include vaginal mesh erosion, infection, bleeding, pain during sexual intercourse, organ perforation, urinary problems, vaginal scarring and neurovascular muscular problems. Remedies include surgery and hospitalization.
Public Citizen issued the petition along with a professor of obstetrics and gynecology at Washington University in St. Louis and a urologic surgeon specializing in female urology and POP at the Mayo Clinic in Rochester, Minn.
The Boston product liability lawyers at Breakstone, White & Gluck are experienced in handling cases involving defective medical devices and dangerous medications. If you have been injured by transvaginal mesh surgery, contact us today for a free legal consultation. We can be reached at 617-723-7676 or use our contact form.
Product Recall: Bunk Beds from Big Lots
A popular bunk bed set is being recalled after a three-year-old boy became entrapped in the frame and died due to asphyxiation.
Big Lots of Columbus, Ohio is recalling 30,000 metal futon bunk beds sold at its stores nationwide from January 2009 through April 2010 for about $200.
The recalled beds have a convertible futon bed on the bottom with a metal ladder leading up to a twin-sized bed. The Consumer Product Safety Commission (CPSC) warns parents that children behind the futon or in the ladder area can become entrapped when the futon and its metal frame are lowered to the flat position.
In March 2010, a young boy from Burlington, Iowa suffered a wrongful death after his head and neck got caught in the bunk bed. The child was unable to breathe and died at the hospital due to compression asphyxiation.
An additional hazard is the space between the last rung on the defective bunk bed’s ladder and the futon mattress is too small, posing a head and neck entrapment hazard.
The Big Lots recall involves metal futon beds with model number BFB1008 located on a label on the upper bunk. The defective beds were sold unassembled and were manufactured in China.
Consumers should immediately stop using the defective bunk beds. They can contact Big Lots for a free repair kit containing a new ladder and other parts.
Consumers can contact Big Lots at (866) 244-5687 during business hours Monday through Friday or visit the retailer’s website at www.biglots.com.
Big Lots has stores throughout Massachusetts, including in Lynn, West Bridgewater, Franklin, Milford, Methuen, Attleboro, Raynham Center, Worcester, Fitchburg, Seekonk, Swansea, Dudley, Gardner, Springfield and Northampton.
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Salmonella in Alfalfa Sprouts Prompts Recall in Massachusetts
UPDATE
Jonathan’s Sprouts of Rochester, MA, has widened the recall of its sprout products due to Salmonella contamination. The recall now includes all sell-by dates, including its conventional, organic, and bulk products. The recall includes other sprouts, such as radish, dill, and gourmet mix. Check below for stores where these products were sold. Do not eat them! Return them to the store for a refund.
More information: FDA Recall Press Release.
ORIGINAL POST
The USDA has found Salmonella, a dangerous bacteria related to food poisoning, in Jonathan’s Alfalfa Sprouts products.
Salmonella, if ingested, can cause serious and sometimes fatal illness and infections in young children, frail or elderly people, and others with weakened immune systems. The symptoms of Salmonella include fever, diarrhea (possibly bloody), nausea, vomiting, and abdominal pain.
Jonathans Sprouts has issued an immediate recall of the following effected products:
- Jonathan’s 4oz Alfalfa Sprouts
- Jonathan’s 4oz Alfalfa with Radish Sprouts
- Jonathan’s 4oz Gourmet Sprouts
- Jonathan’s 4oz Alfalfa with Dill Sprouts
- Jonathan’s 8oz Alfalfa Sprouts
Warning to Massachusetts Residents: Tea Light Candles Recalled Due to Holder Burn/Melt Risk
Over 7 million candles have been recalled due to concerns that the cup holding the candles could melt or catch fire.
The Consumer Product Safety Commission has stated that the defective products, tea light type candles, were sold under the brand names Chesapeake Bay Candle and Modern Light.
The affected candles were sold in Massachusetts and nationwide at retailers such as Home Goods, Target, and Wegmans between July 2009 and February 2011.
The clear plastic cup holding the candles is at risk for melting or igniting during use. There has been one consumer report of the candle’s plastic cup melting during use.
Products Recalled to Protect Children
The U.S. Consumer Product Safety Commission (CPSC) and two companies have issued widespread recalls of defective products that pose a safety hazard to children.
In the first case, Lowe’s has recalled 11 million Roman shades and roll-up blinds. The move is part of a farther-reaching recall that began in December 2009 and has so far involved 25 retailers. Lowe’s sold the largest number of blinds and shades, followed by Ikea. Walmart, JCPenney, Ethan Allen and Jo-Anne Fabric and Craft Stores also sold significant quantities.
The Roman shades and blinds were sold between 1999 and January 2005. Both products can cause strangulation because a child playing could become entangled in the cords and the fabric or plastic blinds.
The recall began after the CPSC learned about two incidents of children who became entangled in the Roman shade’s cord. Neither suffered personal injury. But after the recall was initiated, another 4-year-old boy did suffer personal injury, including rope burn to his neck after getting caught in the cord.
No incidents of personal injury have been reported for the roll-up blinds from this particular store.
Consumers should stop using the shades and contact the Window Covering Safety Council for free repair kits at 800-506-4636.
The CPSC has received five reports of wrongful deaths and 16 near strangulations in Roman shades since 2006. It has received three reports of accidents leading to deaths in roll-up blinds since 2001. The commission recommends consumers use cordless blinds and shades in homes where children visit. If your blinds and shades have cords, keep them inaccessible and install tension devices.
The other product recalled was The First Years American Red Cross Cabinet Swing Locks. About 41,300 locks were sold at Toys R Us, Babies R Us and other retailers.
The locks were designed to keep children from accessing cabinets.
But The First Years company received seven reports of latches breaking. Consumers should stop using the locks immediately and contact the company to obtain a coupon toward purchase of another product. Visit this link for more information.
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