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)
Wednesday, February 16, 2011
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
Tuesday, January 11, 2011
Wednesday, January 5, 2011
Brady The Only Choice For MVP
Brady The Only Choice For MVP: "They said he couldn't win with a bunch of no name receivers. They said he would struggle against Chicago's mightly defense in the snow. They said Rex Ryan figured him out. Yet despite what they keep saying, Tom Brady keeps showing why he's one of a kind. And why the Patriots would be totally lost without him. Brady stands alone as the favorite for League MVP."
Tuesday, December 28, 2010
IIHS Top Safety Picks 2011
As per the Insurance Institute for Highway Safety, the Institute rates vehicles good, acceptable, marginal, or poor based on performance in high-speed front and side crash tests, a rollover test, plus evaluations of seat/head restraints for protection against neck injuries in rear impacts. To earn Top Safety Pick for 2011 a vehicle must have good ratings in all four Institute tests. In addition, the winning vehicles must offer electronic stability control.
(However, don't compare ratings across vehicle size groups because size and weight influence occupant protection in serious crashes. Larger, heavier vehicles generally afford more protection than smaller, lighter ones. Top Safety Picks are the best vehicle choices for safety within size categories, but this doesn't mean a small car that's a Top Safety Pick affords more protection than a bigger car that doesn't earn the award.)Top Safety Picks 2011 are 2011 models, unless otherwise noted.LARGE CARS Buick LaCrosse Buick Regal BMW 5 series (except 4-wheel drive and V8) Cadillac CTS sedan Ford Taurus Hyundai Genesis Infiniti M37/M56 (except M56x 4-wheel drive) Lincoln MKS Mercedes E class coupe Mercedes E class sedan Toyota Avalon Volvo S80SMALL CARS Chevrolet Cruze Honda Civic 4-door models (except Si) with optional ESC Kia Forte sedan Kia Soul Mitsubishi Lancer sedan (except 4-wheel drive) Nissan Cube Scion tC Scion xB Subaru Impreza (except WRX): sedan wagon Toyota Corolla Volkswagen Golf 4-door models Volkswagen GTI 4-door models MINICARS Ford Fiesta built after July 2010: sedan hatchbackMIDSIZE CARS Audi A3 Audi A4 sedan Chevrolet Malibu Chrysler 200 4-door models Dodge Avenger Ford Fusion Hyundai Sonata Kia Optima Lincoln MKZ Mercedes C class Subaru Legacy Subaru Outback Volkswagen Jetta sedan Volkswagen Jetta SportWagen Volvo C30MINIVAN Toyota SiennaLARGE SUV Volkswagen TouaregMIDSIZE SUVs Audi Q5 Cadillac SRX Chevrolet Equinox Dodge Journey Ford Explorer Ford Flex GMC Terrain Hyundai Santa Fe Jeep Grand Cherokee Kia Sorento built after March 2010 Lexus RX Lincoln MKT Mercedes GLK Subaru Tribeca Toyota Highlander Toyota Venza Volvo XC60 Volvo XC90SMALL SUVs Honda Element Hyundai Tucson Jeep Patriot with optional side torso airbags Kia Sportage Subaru Forester Volkswagen Tiguan
For more detail on these vehicles, Click here for the December, 2010, IIHS Status Report.
(However, don't compare ratings across vehicle size groups because size and weight influence occupant protection in serious crashes. Larger, heavier vehicles generally afford more protection than smaller, lighter ones. Top Safety Picks are the best vehicle choices for safety within size categories, but this doesn't mean a small car that's a Top Safety Pick affords more protection than a bigger car that doesn't earn the award.)Top Safety Picks 2011 are 2011 models, unless otherwise noted.LARGE CARS Buick LaCrosse Buick Regal BMW 5 series (except 4-wheel drive and V8) Cadillac CTS sedan Ford Taurus Hyundai Genesis Infiniti M37/M56 (except M56x 4-wheel drive) Lincoln MKS Mercedes E class coupe Mercedes E class sedan Toyota Avalon Volvo S80SMALL CARS Chevrolet Cruze Honda Civic 4-door models (except Si) with optional ESC Kia Forte sedan Kia Soul Mitsubishi Lancer sedan (except 4-wheel drive) Nissan Cube Scion tC Scion xB Subaru Impreza (except WRX): sedan wagon Toyota Corolla Volkswagen Golf 4-door models Volkswagen GTI 4-door models MINICARS Ford Fiesta built after July 2010: sedan hatchbackMIDSIZE CARS Audi A3 Audi A4 sedan Chevrolet Malibu Chrysler 200 4-door models Dodge Avenger Ford Fusion Hyundai Sonata Kia Optima Lincoln MKZ Mercedes C class Subaru Legacy Subaru Outback Volkswagen Jetta sedan Volkswagen Jetta SportWagen Volvo C30MINIVAN Toyota SiennaLARGE SUV Volkswagen TouaregMIDSIZE SUVs Audi Q5 Cadillac SRX Chevrolet Equinox Dodge Journey Ford Explorer Ford Flex GMC Terrain Hyundai Santa Fe Jeep Grand Cherokee Kia Sorento built after March 2010 Lexus RX Lincoln MKT Mercedes GLK Subaru Tribeca Toyota Highlander Toyota Venza Volvo XC60 Volvo XC90SMALL SUVs Honda Element Hyundai Tucson Jeep Patriot with optional side torso airbags Kia Sportage Subaru Forester Volkswagen Tiguan
For more detail on these vehicles, Click here for the December, 2010, IIHS Status Report.
GM Recalls Cadillac CTS for Airbag Defects
GM recalls 100,000 vehicles over crash-safety concerns.
The AP (12/27) reported General Motors is recalling nearly 100,000 vehicles to address issues related to crash safety. Postings with the National Highway Traffic Safety Administration said GM was recalling nearly 96,000 2005 to 2007 models of the Cadillac CTS for airbag defects. GM said "repeated flexing of the sensing mat in the passenger seat can cause the mat to bend or fold so much that the sensor may not detect a passenger is sitting in the seat. Therefore, the sensor wouldn't activate the airbag in the event of a crash." The automaker also recalled about 1,300 2011 models of the Chevrolet Avalanche 1500, GMC Sierra 1500, Cadillac Escalade, and Silverado 1500 for rear axle defects that can cause unexpected crashes.
The AP (12/27) reported General Motors is recalling nearly 100,000 vehicles to address issues related to crash safety. Postings with the National Highway Traffic Safety Administration said GM was recalling nearly 96,000 2005 to 2007 models of the Cadillac CTS for airbag defects. GM said "repeated flexing of the sensing mat in the passenger seat can cause the mat to bend or fold so much that the sensor may not detect a passenger is sitting in the seat. Therefore, the sensor wouldn't activate the airbag in the event of a crash." The automaker also recalled about 1,300 2011 models of the Chevrolet Avalanche 1500, GMC Sierra 1500, Cadillac Escalade, and Silverado 1500 for rear axle defects that can cause unexpected crashes.
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