Accident & Injury Law in Texas

Posts Tagged ‘recall’

General Motors Co. is recalling 1.53 million cars and trucks worldwide because fires can be ignited by components used for heating windshield washer fluid.

The company said Tuesday that it will disable the heating mechanism in the washers of Buick, Cadillac, Chevrolet, GMC, Hummer and Saturn brands from model years 2006 to 2009 and pay owners $100 for each vehicle because the feature won’t be available and the maker of the units is out of business.

Since Toyota Motor Corp. recalled more than 8 million vehicles worldwide this year for defects that may cause unintended acceleration, U.S. regulators have stepped up scrutiny of auto safety, and Congress is considering measures to tighten regulation of the industry.

GM’s heated windshield washer, which the company said was supplied by Micro-Heat Inc., was recalled in 2008 for repairs. The automaker received five reports of fires in the components in the past year, prompting Tuesday’s action, the company said.

The National Highway Traffic Safety Administration had investigated a windshield wiper flaw before GM issued the 2008 recall.

The regulator in 2004 fined GM $1 million, at the time its largest civil penalty, to settle charges the company failed to conduct a timely recall of about 600,000 vehicles for wipers that stopped working or failed to turn on when needed.

Micro-Heat, which filed for bankruptcy in 2008 after GM stopped offering its Hotshot wiper-fluid heater, was based in Farmington Hills, Mich.

GM said in 2008 that Micro-Heat should bear the $19.2 million cost of recalling 944,000 cars and trucks for the earlier recall, according to court papers in the bankruptcy filing.

The recall includes 1,365,070 vehicles in the U.S., 98,794 in Canada, 26,228 in Mexico and 38,093 exported to other countries, GM said. Vehicles included in the U.S. recall are the Buick Enclave and Lucerne; Cadillac CTS, DTS, Escalade, Escalade ESV and Escalade Err; Chevrolet Avalanche, Silverado 3590, Suburban, Tahoe and Traverse; GMC Acadia, Sierra, Yukon and Yukon XL; Hummer H2; and Saturn Outlook.

The Johnson & Johnson unit that recalled millions of bottles of liquid children’s Tylenol and other pediatric medicines last month may face criminal penalties, product seizures or other sanctions, an official from the Food and Drug Administration said last Thursday.

The agency is considering further actions against McNeil Consumer Healthcare, the Johnson & Johnson unit, said Dr. Joshua M. Sharfstein, the FDA’s principal deputy comissioner, at a congressional hearing Thursday.

On April 30, McNeil voluntarily recalled more than 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec because they may have contained too much of the active ingredient of the drug, metal specks or inactive ingredients that failed testing requirements, the agency said. But McNeil’s problems go beyond those related to last month’s recall, including other forms of contamination, dating back two years.

Sharfstein noted lengthy delays by the company in reporting problems to the agency. And in one case, in 2008, he said, McNeil hired a contractor to quietly remove packages of Motrin from retailers for suspected quality problems — which he suggested was essentially an unannounced recall that was not reported to the FDA.

Sharfstein said the FDA was “considering additional enforcement actions against the company for its pattern of noncompliance. which may include seizures, injunction or criminal penalties.”

“I have become deeply concerned about your company,” Rep. Edolphus Towns, chairman of House Committee on Oversight and Government Reform, told the Johnson &. Johnson executive who testified. “It paints a picture of a company that is deceptive, dishonest and that has risked the health of many of our citizens.”

Nissan Motor Co. is planning to recall 48,700 trucks and SUVs for problems with a suspension part that could lead to a rough ride.

Spokesman Colin Price says the company is working on details with the National Highway Traffic Safety Administration and expects the recall to begin this week.

It will cover some, but not all, 2010 Nissan Armadas, Frontiers, Titans, Pathfinders and Xterras and Infiniti QX56 models.

The Armada, Titan and Infiniti QX56 are produced at the company’s Canton, Miss., plant. The Frontier, Pathfinder and Xterra are produced at its Smyrna, Tenn., plant.

No accidents related to the problem have been reported, the company said.

About 170,000 drop-side cribs are being recalled after six infants were injured. The cribs were distributed nationwide from January 2000 to March 2010 under the names C&T International, Sorelle and Golden Baby. Consumers wanting more information should call 877-791-9398.

Anxious parents are scouring the Internet for information after an enormous recall of over-the-counter medications for infants and children that was announced last week.

The recall affects all unexpired lots of liquid Tylenol, Motrin, Zyrtec and Benadryl formulated for youngsters more than 43 products overall.

The U.S. Food and Drug Administration advised families to stop using the products, noting some may contain “tiny particles” while others have too much of the active ingredients or inactive ingredients that don’t meet specifications. McNeil Consumer Healthcare, the manufacturer, and federal officials said the prospect of serious medical problems was “remote.”

For its part, McNeil did little to calm parents’ fears with a hot line (888-222-6036) that featured a verbal rendition of the company’s news release. That release, including a list of all affected products and their lot numbers, is available at www.mcneilproductrecall.com.

McNeil is a unit of Johnson and Johnson.

Families should feel comfortable using generic versions of the drugs, said Dr. Saul Weiner, an associate professor of pediatrics and internal medicine at the University of Illinois at Chicago Medical Center.

If you have given a child one of the medications being recalled, watch out for nausea, vomiting, diarrhea, a rash or “any symptoms that seem out of the ordinary,” said. Jenny Elhadary, pharmacy administrator for Children’s Memorial Hospital.

Call a doctor immediately if the symptoms appear.

Meanwhile, a conressional committee has aunched an investigation into the problems, with lawmakers pledging to crutinize the performance of both the drug maker and federal regulators.

Reps. Edolphus Towns, D-N.Y., and Darrell Issa, R-Calif., the leaders of the House Committee on Oversight and Government Reform, said in a joint statement that they are “deeply concerned” about the recall, which affects an estimated 70 percent of the market for over-the-counter pediatric liquid medicines.

The investigation comes a day after the Food and Drug Administration released documents by federal inspectors who found widespread quality control problems at the Pennsylvania facility where the recalled medicines were manufactured.

Federal investigators found that raw materials had “known contamination” with unspecified bacteria and “were ap proved for use to manufacture several finished lots of Children’s and Infant’s Tylenol drug products.” FDA officials said they couldn’t identify the bacteria.

Samples of finished products tested negative for bacteria, however, and the risk to consumers was remote, agency officials said.

Honda Motor Co. will recall more than 410,00 Odyssey minivans and Element SUVs from the 2007 and 2008 model years because of braking system problems that could make it tougher to stop the vehicle if not repaired.

The National Highway Traffic Safety Administration has reported three crashes due to the problem with minor injuries and no deaths, a Honda spokesman said.

A day after Toyota Motor Corp. announced an indefinite suspension of U.S. sales on an unprecedented scale to fix faulty gas pedals, the automaker said late Wednesday that it will recall an additional 1.1 million vehicles in the United States over floor mat problems. Toyota said Thursday’s recall would affect five models: 2008-10 Highlander, 2009-10 Corolla, 2009-10 Venza, 2009-10 Matrix and 2009-10 Pontiac Vibe.

Toyota said late Tuesday that it would halt sales of some of its top-selling models to fix gas pedals that could stick and cause unintended acceleration. Last week, Toyota issued a recall for the same eight models, affecting 2.3 million vehicles.

The suspect accelerator parts are made by a U.S. supplier, but similar parts are also found in its European-made vehicles, an official with the Japanese automaker said Wednesday. Toyota said it hasn’t decided what to do there.

Tuesday’s announcement follows a larger U.S. recall last year of 4.2 million vehicles because of problems with gas pedals becoming trapped under floor mats, causing sudden acceleration.

That problem was the cause of several crashes, including some fatalities.

Toyota has said it was not aware of any accidents or injuries due to the pedal problems associated with last week’s recall. About 1.7 million vehicles fall under both recalls.

Toyota is also suspending production at six North American car-assembly plants beginning next week and gave no date on when production could restart.

The sales and production, halt involves several best-selling U.S. models, including the Camry and Corolla sedans, the Tundra truck and the RAV4 crossover, a blend of an SUV and a car.

Toyota said the sales suspension wouldn’t affect Lexus or Scion vehicles and that the Prius, Tacoma, Sienna, Venza, Solara, Yaris, 4Runner, FJ Cruiser, Land Cruiser and select Camry models, including all Camry hybrids, would remain for sale. Those vehicles contain gas pedals produced by a different North American supplier than the one whose parts are involved in the current sales halt, Toyota has said.

The supplier is CTS Corp., based in Elkhart, Ind., and.he suspect part was manufactured at its plant in Ontario, according to a report Toyota gave the U.S. National Highway Traffic Safety Administration last week. CTS said Toyota told it  about fewer than a dozen cases in which drivers struggled with pedals.

David Strickland, the administrator of the federal traffic safety agency, said that the Transportation Department had been in regular communication with Toyota about the recall. Strickland said Toyota’s decision to stop selling the vehicles was “an aggressive one and one that is the legal and morally Correct thing to do.” Rental car firms Avis Budget Group and Enterprise Holdings said they were pulling thousands of Toyota models covered by last week’s recall until a fix is available.

Avis Budget said the decision to idle 20,000 Toyotas was a precaution. Enterprise Holdings, which controls the Enterprise, National and Alamo brands, said it would pull an unspecified number of Toyota models from its fleet.

Toyota expects to sell 2.2 million vehicles in North America in 2010, up 11 percent from 2009, according to sales targets released Tuesday. Toyota said it was planning global sales of 8.3 million vehicles this year, up 6 percent from 2009, but those numbers do not account for the U.S. sales stoppage.

Two years ago, Toyota beat out General Motors Co. to become the world’s largest automaker. Now just weeks into 2010, it is halting some sales in the U.S., its biggest market.

Three years ago, the maker of a surgical clip called the Hem-o-lok issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge in their bodies, with “serious, even life-threatening consequences.”

Experts say deaths resulting from missed recalls are the result of a major weakness in the nation’s system for recalling thousands of medical devices routinely implanted in people’s bodies, from screws and plates to artificial knees and hips.

“There is no system for being informed of what the problems are with the products you have in your body. Even your physician may not know,” said Terry Fadem, president of the Biomedical Research and Education Foundation in Philadelphia.
Unlike the auto industry, medical equipment makers have no centralized system for tracking products throughout their life span. That means in some instances, manufacturers do not have an easy way of knowing where problematic devices are or which patients got them.

Meanwhile, the number of items implanted is soaring, as is the number of recalls. Nearly 2,500 medical devices were recalled for potential safety problems in fiscal 2008, according to the Food and Drug Administration. That was nearly double the number reported the previous year and a 164 percent increase since 2000.

In 2006, surgeons implanted a million hip and knee replacements, according to the American Academy of Orthopaedic Surgeons. That number is expected to quadruple by 2030.

Fadem’s foundation and other groups have been pushing for years for better tracking of devices, hoping to create something like the patient registries used in Sweden, England and Australia to keep tabs on artificial joints.

Health care overhaul legislation being considered in Congress includes a proposal to set up the nation’s first comprehensive medical device registry. Doctors say its primary use would be to uncover safety problems, but it could also be used to find patients quickly during a recall.

The. FDA currently requires comprehensive tracking of only 14 types of devices, including pacemakers, mechanical heart valves and breast implants. The agency says it is working toward better registration and tracking of other devices.

Manufacturers trace many other medical products only as far as the distributor. Finding them again is not always easy, particularly after they have been implanted into someone’s body. Hospitals record the model and lot numbers of implants, but that information is often buried deep in billing records or log books.

Manufacturers send out thousands of letters about recalls, and the FDA puts the information online, but the warnings can go unnoticed.

More than 1,000 such recall notices were sent out in the first seven months of 2009 involving devices such as tracheal tubes, catheters, pacemakers, prosthetic hips, screws, pain pumps and pieces of artificial spine. More than 1,00 were ranked as “Class 1″ recalls by the FDA, which involve a defect serious enough to create a “reasonable probability of adverse health consequences or death.”

Premier Inc., an alliance of 2,200 U.S. hospitals, said it examined one recent recall and found that even after a device with a potentially dangerous flaw was pulled from the market, doctors at more than 40 hospitals implanted it in at least 50 patients.

The FDA has been laying the groundwork for a registry of patients with artificial joints, which are more prone to breakage than other types of implants. The agency is also working on a system that would make tracking easier by associating each device with an ID number.

Toyota Motor Corporation said it will recall 3.8 million vehicles in the United States, the company’s largest-ever U.S. recall, to address problems with a removable floor mat that could cause accelerators to get stuck and lead to a crash. The recall will involve models such as the Toyota Camry, the top-selling passenger car in America, and the hybrid Prius. Toyota. said it is working to find a remedy and that owners could be notified as early as next week.