Hospira recalls devices on heels of FDA warning letter
This article was originally published in The Silver Sheet
Executive Summary
Drug-delivery device maker Hospira initiated a nationwide recall Aug. 14 of more than 30 types of devices with defective power cords that may crack and fail, potentially resulting in electrical shock, therapy delays, device failure and fires. The devices include the Acclaim Encore infusion pump, Omniflow and GemStar medication management system components, Q2 and QVue cardiac monitoring systems, and items in the LifeCare and Plum infusion pump lines. The recall came two days after FDA sent a warning letter to Hospira citing quality system regulation violations related to the faulty cords (See "1Warning Letters."
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FDA Warning Letters
The following chart lists medical device-related warning letters released by FDA from Aug. 11 through Sept. 8. If an inspection led to the warning letter, the location of the inspected facility and dates of inspection are noted; otherwise, the location of the warning letter recipient is listed.
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