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Archive for August, 2006

Cardinal Stops Production of Defective Drug Pump after FDA has U.S. Marshalls Confiscate Devices

Wednesday, August 30th, 2006

Cardinal Health announced that it stopped production of four Alaris drug infusion pumps. The announcement came after the FDA requested that U.S. marshals confiscate 1,300 devices out of the company’s San Diego facility on Friday. The Alaris pumps, which are used to regulate the delivery of intravenous drugs to patients, have been linked to at least two deaths due to an oversensitive keypad.

According to the FDA the defect in the keypad causes “key bounce,” which occurs when a number entered into the keypad is recorded more than once. If the intended dose is 3.5 milliliters per hour, the defective keyboard could actually enter 33.5 milliliters into the pump, and can cause a serious overdose.
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Workers Exposed to Lead are 50 Percent More Likely to Die from Brain Cancer than those not Exposed

Tuesday, August 29th, 2006

Occupational exposure to lead dramatically increases the risk of devloping and dying from brain cancer, according to a report published in the International Journal of Cancer. The report by leading epidemiologists analyzed over 300,000 workers and found the riskiest occupations were welders, auto mechanics, heavy equipment mechanics. Individuals heavily exposed to lead at work were more than two times as likely to die from brain cancer as nonexposed workers.
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Bausch & Lomb ReNu with MoistureLoc Recall History

Monday, August 28th, 2006

ReNu with MoistureLoc was removed from the market after the CDC discovered numberous cases of fusarium keratitis were linked to the product. The recall has slowed the outbreak of the fungal eye infection but it is estimated that MoistureLoc still holds over 2 percent of the market, because many people are still unaware that the solution has been recalled. Below is a detailed timeline of Bausch Lomb’s ReNu with MoistureLoc.

May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution:
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