Earlier this month the FDA issued a Class I Recall on defibrillator wires that connect implanted defibrillators to the heart. The wires, (leads) were manufactured by Medtronic Inc., one the leaders in this market. The Sprint Fidelis leads were linked to several reports of patients receiving unwarranted shocks from their defibrillators. Plaintiffs' attorneys have begun filing lawsuits against the...
The FDA has issued a Class I Recall for possible fracture risks of Medtronic Defibrillator Leads. The recall comes one day after the company issued a warning of possible fracture dangers and voluntarily stopped distribution of suspected products. The FDA says that fracture risks can be associated with a very small percentage of manufactured leads however they are taking fast and furious action....
Just when you thought the toy recalls had finally passed, today comes news of a seven new recalls. The recalls all have been issued in association of unsafe levels of lead paint. Over 600,000 new toys and children's jewelry are affected by the recall. About 200,000 units of Thomas & Friends railway toys are involved in the most recent recall. The Chicago based company, RC2 Corp., that...
Mattel has issued yet another toy recall due to unsafe amounts of lead. This most recent of the three recalls that have been issued over the past five weeks includes about 848,000 toys worldwide. It covers 11 toys in all, eight from the Barbie name and the other three were sold under the Fisher-Price name. The company has now recalled almost 21 million toys since August 1st. Many were recalled...
Patients should review the latest information to see if they have been implanted with the recalled device and seek medical attention right away if symptoms occur. Patients who have received one of the recalled hernia mesh patches may also qualify for medical monitoring and compensation from the manufacturer. Accurate testing of the Kugel Mesh Patch would have showed the defects of the device and...
April 3, 2006 -- The US Food and Drug Administration (FDA) and Davol, Inc. have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device to include all lots of the oval "midline" size, and lots manufactured before 2004 of the large oval and large circle products. The recall previously affected only the extra-large oval patch.The recall is...
Doctors have been advised to stop using the Kugel Mesh Patch and the FDA is recommending that patients who were implanted with Patches on the recall list seek immediate medical attention if they experience unusual symptoms. The Kugel Mesh Patch is used to repair a ventral hernia. A hernia is described by doctors as a defect of gap in the abdominal muscle wall through which an intra-abdominal...
The FDA has announced an upgrade to the recall on Kugel Mesh Hernia Patches to a "Class 1" because the defective devices can cause serious health problems and possibly even death.According to the FDA Recall Notice, it advises patients to review the latest information on the recall to see if they have been implanted with the recalled device. If any medical symptoms arise, patients should seek...
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