October 28, 2009

Insulin Syringe and Catheter Sheath Medical Device Recalls

Yesterday, all Accusure insulin syringes distributed since January 2002 were recalled by device manufacturer Qualitest Pharmaceuticals. The Huntsville, AL-based manufacturer of Accusure estimates the recall affects 250 million insulin syringes. So far, the company has admitted four reports of the needle detaching from the syringe. These recalled Accusure insulin syringes were distributed wholesale and at retail pharmacies throughout the U.S., including Tennessee.

Previously, Qualitest Pharmaceuticals recalled two lots of syringes distributed in 2007 and 2008. This week's recall expands the range of potentially unsafe insulin syringes back to those Qualitest has distributed since January 2002. These recalled medical products have the following descriptions and national drug codes:

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October 3, 2009

Device Recall of 5,400 Defective Philips Defibrillators

Philips Electronics, a Dutch company, announced a recall this Tuesday of 5,400 defibrillators for potential defective memory chips. The majority of these defective medical devices being recalled are defibrillators sold in the U.S. These memory chip failures render the device inoperable.

Affected defibrillators are Select HeartStart FR2+ Automated External Defibrillators (AED) (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical). These medical devices were manufactured between 5/2007 – 1/2008.

Downplaying the seriousness of this recall of these medical devices on market for over two years, a Philips spokesperson stated that his company sells so many defibrillators worldwide that “the recall [of 650,000 potentially defective defibrillators] represents less than 1 percent [sold].”

Defibrillators are used by response teams to respond to sudden cardiac arrest by helping restart a patient's heart. Other device manufacturers have recently recalled their defective AEDs for software flaws, inability to function in humid conditions, and other potentially fatal manufacturing errors. AEDs affected by the Phillips' medical device recall will impact hospitals, first responders (fire departments and EMS), and other emergency and health organizations.

Philips is one of the world’s top three hospital equipment companies. So far no reports of injury due to product failure have been reported in Tennessee. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

If a Philips or another brand of defective defibrillator has caused harm to you or a loved one, contact Higgins Firm to explore your legal options with a defective medical device lawyer. Call 1.800.705.2121 or complete our defective medical device injury form. Our injury lawyers accept cases throughout Tennessee and select cases in Georgia and Kentucky.

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September 18, 2009

Dangerous Medical Device Recalls – Medtronic and the FDA

Medtronic, the medical device manufacturer, has had many of its medical products subject to a flurry of Class I recalls and warnings in recent months. These include Medtronic catheters, defibrillators, and pacemakers being issued the FDA most severe warnings for defects that may cause potentially severe injuries.

Medtronic’s Sutureless Connector intrathecal catheters (SC catheters) were recalled for labeling errors that have already negatively affected 10 patients when, per company instructions, the catheter was used with the Medtronic IsoMed Pump Model 8472, a constant-flow infusion drug pump Medtronic discontinued last year as part of a "planned product phase-out." What some might see as a minor oversight in printing--unless you’re one of the nine patients depending on the pumps’ cancer-fighting drugs whose catheters became disconnected and who required surgery to correct the problem, especially if you’re one of the nine who died two days following the procedure.

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