Imagine if you will the scenario of you being operated on and all of a sudden the operating table suddenly moved or tilted during the surgery. I honestly couldn’t imagine. But, apparently there have been a number of reported injuries to the FDA of this exact thing happening. Reports that Mizuho operating tables could suddenly …
A public advocacy group, Public Citizen, founded by Ralph Nader, is asking the U.S. Food and Drug Administration to recall transvaginal surgical mesh products that help repair pelvic organ prolapse and stress urinary incontinence, just as the industry is preparing a broad response.
Company, Product(s): Baxter Healthcare Corporation HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems Recall Class: Class I Date Recall Initiated: January 8, 2010 Product Names: Baxter Healthcare Corporation, HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. These systems have been distributed since 1994.
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as …
Thoratec Corporation recalled the HeartMate II Left Ventricular Assist System. The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the heart.
Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are …