Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Power cord investigation: FDA is investigating power cords used in devices manufactured by Abbott, Hospira and other firms. Abbott and Hospira have collectively sent FDA 122 reports of sparking, charring and fires from defective device AC power cords manufactured by Westfield, Pa.-based Electri-cord Manufacturing Co. The power cord's prongs may crack and fail, potentially causing electrical shock, therapy delays or interruption, device failure or fires. FDA is determining which other device firms have been supplied with the cords and recommends that manufacturers that use the cords initiate voluntary recalls and report any adverse events to FDA. Hospira recalled more than 30 types of devices with the defective cords Aug. 14 (1"The Gray Sheet" Aug. 24, 2009). Electri-cord said Aug. 19 the problems must be related to "abusive use," such as yanking the cord out of the wall, rather than a manufacturing defect
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