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ZOLL EXTERNAL DEFIBRILLATOR COMPONENT TRACKING IS INADEQUATE

This article was originally published in The Gray Sheet

Executive Summary

ZOLL EXTERNAL DEFIBRILLATOR COMPONENT TRACKING IS INADEQUATE, FDA says in a Dec. 10 warning letter to the Burlington, Massachusetts-based company. FDA states that "the lot numbers for the K1 relay...are not adequately tracked to determine the lot number of the relay used in a specific defibrillator." "Failures of these K1 relays resulted in the Class I recall of defibrillators," FDA notes. In June, Zoll initiated a recall of 1,467 PD 1200 and 622 D900 external defibrillators ("The Gray Sheet" Nov. 29, p. 9). The warning letter is based on a Aug. 25- Oct. 1 inspection of Zoll's manufacturing facility.
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