FDA Classifies Riata and Riata ST Silicone Defibrillation Leads as Class I Recall
December 16, 2011
The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians. The FDA’s classification updates the recommendations provided in the Nov. 28, 2011 Physician Advisory Letter, which is available on the company’s website, www.sjmprofessional.com. An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December 2010. The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).
Abbott Diabetes Care Recalls Certain Lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips
December 24, 2010
The test strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium and OptiumEZ blood glucose monitoring systems. ReliOn Ultima test strips are used with the ReliOn Ultima blood glucose monitoring system. The blood glucose monitors are not being recalled and customers can continue to use the blood glucose monitors.
Bassettbaby Recalls to Repair Drop-Side Cribs Due to Entrapment, Suffocation and Fall Hazards
November 23, 2010
WASHINGTON, D.C. – THE U.S. CONSUMER PRODUCT SAFETY COMMISSION, IN COOPERATION WITH THE FIRM NAMED BELOW, TODAY ANNOUNCED A VOLUNTARY RECALL OF THE FOLLOWING CONSUMER PRODUCT. CONSUMERS SHOULD STOP USING RECALLED PRODUCTS IMMEDIATELY UNLESS OTHERWISE INSTRUCTED. IT IS ILLEGAL TO RESELL OR ATTEMPT TO RESELL A RECALLED CONSUMER PRODUCT.
Darvocet Recall – Potentially Fatal Heart Abnormalities Final Straw
November 20, 2010
Xanodyne Pharmaceuticals, Inc. is cooperating with the FDA in recalling Darvocet and Darvon, their versions of the pain killer propoxyphene. Darvon, which is also sold as Darvocet (with acetaminophen added), could cause serious and potentially fatal heart rhythm abnormalities, according to new clinical data reviewed by the FDA.
Deaths Prompt CPSC, FDA Warning on Infant Sleep Positioners
September 20, 2010
WASHINGTON, D.C. – THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) AND THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) TODAY WARNED CONSUMERS TO STOP USING INFANT SLEEP POSITIONERS. OVER THE PAST 13 YEARS, CPSC AND THE FDA HAVE RECEIVED 12 REPORTS OF INFANTS BETWEEN THE AGES OF 1 MONTH AND 4 FOUR MONTHS WHO DIED WHEN THEY SUFFOCATED IN SLEEP POSITIONERS OR BECAME TRAPPED AND SUFFOCATED BETWEEN A SLEEP POSITIONER AND THE SIDE OF A CRIB OR BASSINET.
Integra Issues Urgent Worldwide Recall of NeuroBalloonTM Catheter
August 25, 2010
Integra LifeSciences Corporation, Plainsboro, New Jersey, has initiated a worldwide recall of the NeuroBalloon Catheter. There were a total of 1,924 units distributed, 258 in the United States of America 1,586 in the European Union and 80 in countries. A total of eight (8) complaints regarding the inflation or deflation of the NeuroBalloon Catheter were received by Integra. All complaints occurred outside the United States. No patient injuries have been reported. As a result of the investigation performed by Integra, it was determined that this condition could exist during pre-implant testing or during the procedure. Integra issued a voluntary recall of the affected lots of the NeuroBalloon Catheter on July 2, 2010. The FDA is expected to classify this recall as a Class I recall. Class 1 recalls are FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Child’s Death Prompts Recall to Repair Portable Playard Tent by Tots in Mind
July 16, 2010
WASHINGTON, D.C. – THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) AND HEALTH CANADA (HC), IN COOPERATION WITH TOTS IN MIND INC., OF SALEM, N.H., IS ANNOUNCING THE VOLUNTARY RECALL TODAY OF ABOUT 20,000 (AND 85 IN CANADA) COZY INDOOR OUTDOOR PORTABLE PLAYARD TENTS PLUS CABANA KITS.
Aqua Lung America Recalls Apeks WTX Power Inflators Due to Drowning Hazard
July 1, 2010
NAME OF PRODUCT: POWER INFLATOR
UNITS: ABOUT 1,380 IN THE U.S., 530 IN CANADA
IMPORTER: AQUA LUNG AMERICA OF VISTA, CALIF.
HAZARD: THE ORAL INFLATOR BUTTON IS NOT PROPERLY BONDED TO THE ORAL STEM AND CAN FALL OFF DURING USE, POSING A LEAK OF THE BUOYANCY COMPENSATOR CONTENTS. THIS POSES A DROWNING HAZARD.
Infant Death Prompts Recall of Ring Slings Made by Sprout Stuff Due to Suffocation Risk
June 3, 2010
WASHINGTON, D.C. – THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC), IN COOPERATION WITH SPROUT STUFF, OF AUSTIN, TEXAS, IS ANNOUNCING THE RECALL OF ABOUT 40 SPROUT STUFF INFANT RING SLINGS. CPSC ADVISES CONSUMERS TO IMMEDIATELY STOP USING THESE SLINGS DUE TO A RISK OF SUFFOCATION TO INFANTS.
Target Recalls Storage Trunks Due to Strangulation Hazard
May 21, 2010
HAZARD: THE LID OF THE TRUNK CAN DROP SUDDENLY WHEN RELEASED, POSING A STRANGULATION HAZARD TO SMALL CHILDREN OPENING OR REACHING INTO THE TRUNKS.
NAME OF PRODUCT: WOVEN STORAGE TRUNKS
UNITS: ABOUT 350,000
IMPORTER: TARGET CORP., OF MINNEAPOLIS, MINN.
CPSC Issues Warning on Drop-Side Cribs
May 8, 2010
WASHINGTON, D.C. – AS PART OF ITS COMMITMENT TO ENSURE SAFE SLEEP FOR YOUNG CHILDREN, THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) IS ONCE AGAIN WARNING PARENTS AND CAREGIVERS ABOUT DEADLY HAZARDS WITH DROP-SIDE CRIBS. IN THE LAST FIVE YEARS, CPSC HAS ANNOUNCED 11 RECALLS INVOLVING MORE THAN 7 MILLION DROP-SIDE CRIBS DUE TO SUFFOCATION AND STRANGULATION HAZARDS CREATED BY THE DROP SIDE. CPSC STAFF IS ACTIVELY INVESTIGATING SEVERAL OTHER CRIB MANUFACTURERS FOR POTENTIAL DROP-SIDE HAZARDS AS PART OF A LARGER EFFORT BY THE AGENCY TO RID THE MARKETPLACE AND HOMES OF UNSAFE CRIBS. CPSC WILL CONTINUE TO TAKE AGGRESSIVE ACTION TO ADDRESS ANY RISKS AND WILL KEEP THE PUBLIC INFORMED.
CPSC Announces Recalls to Repair Millions of Roman Shades and Roll Up Blinds by Multiple Firms
December 17, 2009
THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) IS ANNOUNCING THAT MULTIPLE FIRMS ARE RECALLING MILLIONS OF UNITS OF WINDOW COVERINGS, INCLUDING ROMAN SHADES AND ROLL-UP BLINDS. THESE WINDOW COVERINGS PRESENT A SERIOUS RISK OF STRANGULATION TO YOUNG CHILDREN.
Synthes USA, Ti Synex II Vertebral Body Replacement
November 13, 2009
| Recall Class: | Class I | ||
| Date Recall
Initiated: |
September 14, 2009 | ||
| Product: |
Ti Synex II Vertebral Body Replacement (VBR)
This recall involves part numbers 04.808.001-11, Synex II Central Body, Titanium (all lots).
|
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter
November 10, 2009
| Recall Class: | Class I |
| Date Recall
Initiated: |
September 24, 2009 |
| Product: |
CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65 This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009. |
Penumbra Recalls the Original Version of 6F Neuron 070 Delivery Catheter
October 1, 2009
Penumbra is initiating a voluntary Field Removal of the original version of Neuron 6F 070 Delivery Catheter. For these catheters, Penumbra has received feedback from some users that the catheter could kink or ovalize in certain anatomical situations. This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death.
Toyota Recalls 3.8 Million Vehicles: Gas Pedals Sticking
September 30, 2009
Also See: Toyota Recall: Four Different Causes. So Which is it?
Toyota / Lexus and the National Highway Traffic Safety Administration (NHTSA) are warning drivers about the potential for drivers-side floor mats to cause the accelerator (gas pedal) to stick. This recall affects 3.8 million vehicles.
Sitagliptin – Januvia and Janumet – Type Two Diabetes Drugs and Acute Pancreatitis
September 25, 2009
The FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these medications for type two diabetes.
Eighty-eight post-marketing cases of acute pancreatitis were reported to the Agency between October 2006 and February 2009. These include two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin.
Eddie Bauer Play Yards with Rocking Bassinets Recalled Due to Suffocation Hazard
May 14, 2009
Eddie Bauer Soothe & Sway Play Yards
UNITS: About 71,000 in the United States
DISTRIBUTOR: Dorel Juvenile Group Inc., of Columbus, IN
Recalled Terumo Tenderflow Pediatric Arterial Cannulae
December 9, 2008
Terumo Cardiovascular Systems (Terumo CVS) has issued an urgent, worldwide recall of all Tenderflow pediatric arterial cannulae with the lot codes shown below.
Infant Death From Convertible Cribs by Playkids USA
October 17, 2008
THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC), IN COOPERATION WITH PLAYKIDS U.S.A. OF BROOKLYN, N.Y. IS ANNOUNCING TODAY A VOLUNTARY RECALL OF ABOUT 2,000 CONVERTIBLE CRIBS. THE SIDES OF THE RECALLED CRIBS ARE MADE OF A MESH THAT EXPANDS, CREATING A GAP BETWEEN THE MATTRESS AND THE SIDE THROUGH WHICH AN INFANT CAN SLIP. THIS POSES SUFFOCATION AND ENTRAPMENT HAZARDS FOR YOUNG CHILDREN.
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