Volkswagen AG vehicles are under review by the U.S. National Highway Traffic Safety Administration after reports of engines stalls, some at highway speed, that may be related to fuel-pump failures.
The auto-safety regulator received reports of one accident and 160 complaints from owners and the company about engine loss of power and stalling, NHTSA said in a posting on its website today. The power loss and stalling was related to high-pressure pumps failing and contaminating the fuel system with debris, the agency said.
About half of the reports involved stalling with “many of these alleging stall incidents at highway speeds in traffic with no restart,” the agency said.
NHTSA is reviewing model years 2009 and 2010 of the Volkswagen Jetta and Golf and the Audi A3 that have TDI clean- diesel engines, totaling about 97,272 vehicles.
The regulator, which received 52 of the complaints directly and the rest through the Wolfsburg, Germany-based automaker, upgraded its investigation to an engineering analysis, a step that can lead to a recall.
“We take these matters very seriously and are cooperating fully with NHTSA during its investigation,” Sheriece Matias, a U.S.-based spokeswoman for Volkswagen, said in an e-mail. “We will continue to work closely with the agency as the analysis continues
Thursday, February 17, 2011
Dorel Juvienile Group Recalls 800,000 Child Saftey Seats for failure to lock properly
NEW YORK (CNNMoney) -- Dorel Juvenile Group has recalled nearly 800,000 child safety seats because they do not always lock properly, the government said Monday.
The recall covers certain infant, convertible and booster child restraint systems that were made between May 2008 and April 2009, the National Highway Traffic Safety Administration said. The seats were sold individually or as part of a "travel system" with a stroller.
NHTSA said the harness locking and release button on the seats does not always return to its locked position, which could lead to loose straps. In the event of a crash, the child wouldn't be tightly fastened in, which could result in injuries, the agency said.
As a remedy, Dorel will send registered owners a small tube of "food-grade lubricant" that is designed to prevent sticking and ensure that the harness button works properly.
Dorel said in a statement that the recall "is being conducted out of an abundance of caution with no reported incidents or injuries."
"Parents and caregivers are being provided detailed information on how to make the simple recommended adjustments to their car seat," the company said.
NHTSA said consumers can continue to use the seats until the lubricant is applied, but the agency said caregivers should make sure harness is properly adjusted and locked.
The recall covers certain infant, convertible and booster child restraint systems that were made between May 2008 and April 2009, the National Highway Traffic Safety Administration said. The seats were sold individually or as part of a "travel system" with a stroller.
NHTSA said the harness locking and release button on the seats does not always return to its locked position, which could lead to loose straps. In the event of a crash, the child wouldn't be tightly fastened in, which could result in injuries, the agency said.
As a remedy, Dorel will send registered owners a small tube of "food-grade lubricant" that is designed to prevent sticking and ensure that the harness button works properly.
Dorel said in a statement that the recall "is being conducted out of an abundance of caution with no reported incidents or injuries."
"Parents and caregivers are being provided detailed information on how to make the simple recommended adjustments to their car seat," the company said.
NHTSA said consumers can continue to use the seats until the lubricant is applied, but the agency said caregivers should make sure harness is properly adjusted and locked.
Wednesday, February 16, 2011
Toyo Tire recall
NHTSA Campaign ID Number: 11T001
Synopsis:
Toyo Tire is recalling certain Toyo brand tires, models Versado CUV P245/55 R19 103T, Versado CUV P235/55Rr20 102T, Versado CUV 235/55 R18 100V, Versado CUV P255/65R18 109S, Versado LX II 215/60Rr16 95V, Open Country All Terrain LT285/70 R17 121S, and Tourevo LS II 245/45R18 96V; and Nitto brand Terra Grappler All Terrain 255/55R18 109S, produced from September 19, 2010, through October 2, 2010. The rubber chemical mixture used in some of the recalled tires does not meet Toyo's specification for these tires. Sections of the tread may become detached, potentially causing loss of vehicle control, possibly resulting in a crash. Toyo will notify owners and replace the tires free of charge, including mounting, balancing and taxes. The safety recall is expected to begin on or about February 18, 2011. Owners may contact Toyo toll-free at 1-800-442-8696 (6:30 am to 5:00pm pacific time) or Nitto at 1-888-529-8200 (8am to 5pm pacific time).
For more information for this particular recall, please go to 11T001.
Thank you,
Recalls Subscription Team
Office of Defects Investigation (ODI)
National Highway Traffic Safety Administration (NHTSA)
U.S. Department of Transportation (DOT)
Synopsis:
Toyo Tire is recalling certain Toyo brand tires, models Versado CUV P245/55 R19 103T, Versado CUV P235/55Rr20 102T, Versado CUV 235/55 R18 100V, Versado CUV P255/65R18 109S, Versado LX II 215/60Rr16 95V, Open Country All Terrain LT285/70 R17 121S, and Tourevo LS II 245/45R18 96V; and Nitto brand Terra Grappler All Terrain 255/55R18 109S, produced from September 19, 2010, through October 2, 2010. The rubber chemical mixture used in some of the recalled tires does not meet Toyo's specification for these tires. Sections of the tread may become detached, potentially causing loss of vehicle control, possibly resulting in a crash. Toyo will notify owners and replace the tires free of charge, including mounting, balancing and taxes. The safety recall is expected to begin on or about February 18, 2011. Owners may contact Toyo toll-free at 1-800-442-8696 (6:30 am to 5:00pm pacific time) or Nitto at 1-888-529-8200 (8am to 5pm pacific time).
For more information for this particular recall, please go to 11T001.
Thank you,
Recalls Subscription Team
Office of Defects Investigation (ODI)
National Highway Traffic Safety Administration (NHTSA)
U.S. Department of Transportation (DOT)
Tuesday, February 15, 2011
Recalled medical devices mostly untested
Recalled medical devices mostly untested, report says.
Two of the major television networks and a number of newspapers and consumer medical sites discussed a study published online Feb. 14 in the Archives of Internal Medicine about a possible link between fast approval of some medical devices and their subsequent recall. ABC World News (2/14, story 7, 2:55, Sawyer) reported "a new warning about some of the medical devices so many Americans have implanted," including "replacement hips and knees, heart valves," and "pacemakers."
The CBS Evening News (2/14, story 6, 2:25, Couric) reported, "The FDA approves new medical devices in the hopes of saving lives, but in 2006, some devices were linked to more than 2,800 deaths and close to 120 injuries. Today," a paper in "the Archives of Internal Medicine urged the FDA to improve the way devices are tested before they reach the public."
On the front of its Business Day section, the New York Times (2/15, B1, Meier) reports, "Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale." Researchers Diana M. Zuckerman, PhD, and Paul Brown, of the National Research Center for Women & Families, along with Steven E. Nissen, MD, of the Cleveland Clinic, "found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing."
"Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives," the Washington Post (2/15, Stein) reports. "Most of the devices -- 71 percent -- had been approved without undergoing testing in people."
On its front page, the Los Angeles Times (2/15, A1, Zajac) reports, "Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review," and "only 21 of the recalls in the new study involved products approved after clinical trials."
"The study found that most medical devices that were recalled over serious risks to patients were cleared through the Food and Drug Administration's 510(k) approval process or were exempt from regulatory scrutiny entirely," the Minneapolis Star Tribune (2/15, Moore) reports, explaining that "the 510(k) process requires device manufacturers to prove a new product is 'substantially equivalent' to one currently on the market -- usually without clinical data to prove the product is safe and effective." Because of previous criticism of this pathway to approval from both Congressional officials and consumer advocacy groups, "Dr. Jeffrey Shuren, the FDA's new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer."
Millions "may be at risk." According to the AP (2/15, Tanner), an invited commentary accompanying the study "says the analysis shows that 'millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data.'"
Modern Healthcare (2/15, McKinney) quotes the study authors' conclusion: "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy."
Two of the major television networks and a number of newspapers and consumer medical sites discussed a study published online Feb. 14 in the Archives of Internal Medicine about a possible link between fast approval of some medical devices and their subsequent recall. ABC World News (2/14, story 7, 2:55, Sawyer) reported "a new warning about some of the medical devices so many Americans have implanted," including "replacement hips and knees, heart valves," and "pacemakers."
The CBS Evening News (2/14, story 6, 2:25, Couric) reported, "The FDA approves new medical devices in the hopes of saving lives, but in 2006, some devices were linked to more than 2,800 deaths and close to 120 injuries. Today," a paper in "the Archives of Internal Medicine urged the FDA to improve the way devices are tested before they reach the public."
On the front of its Business Day section, the New York Times (2/15, B1, Meier) reports, "Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale." Researchers Diana M. Zuckerman, PhD, and Paul Brown, of the National Research Center for Women & Families, along with Steven E. Nissen, MD, of the Cleveland Clinic, "found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing."
"Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives," the Washington Post (2/15, Stein) reports. "Most of the devices -- 71 percent -- had been approved without undergoing testing in people."
On its front page, the Los Angeles Times (2/15, A1, Zajac) reports, "Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review," and "only 21 of the recalls in the new study involved products approved after clinical trials."
"The study found that most medical devices that were recalled over serious risks to patients were cleared through the Food and Drug Administration's 510(k) approval process or were exempt from regulatory scrutiny entirely," the Minneapolis Star Tribune (2/15, Moore) reports, explaining that "the 510(k) process requires device manufacturers to prove a new product is 'substantially equivalent' to one currently on the market -- usually without clinical data to prove the product is safe and effective." Because of previous criticism of this pathway to approval from both Congressional officials and consumer advocacy groups, "Dr. Jeffrey Shuren, the FDA's new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer."
Millions "may be at risk." According to the AP (2/15, Tanner), an invited commentary accompanying the study "says the analysis shows that 'millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data.'"
Modern Healthcare (2/15, McKinney) quotes the study authors' conclusion: "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy."
Tuesday, January 18, 2011
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