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Sims Portex 1st Response

This article was originally published in The Gray Sheet

Executive Summary

Failure of a user to adjust the positive end expiratory pressure (PEEP) valve on the manual resuscitator was the cause of a single reported injury in November 2002 that led to a voluntary Class I recall, the firm says. Corrective actions taken include packaging new PEEP valves separately at the lowest setting (5 cmH2O), instead of attached to the resuscitator at the highest setting (20 cmH2O). A high PEEP valve setting can leave residual air in the lungs, according to the company. Cleared via 510(k) in February 2002, about 10,000 units were distributed prior to the recall, FDA states. A replacement or credit was offered by the firm for returned units. However, Sims Portex, which leads the U.S. manual resuscitation market with a 37% share, says the recall will have a non-significant financial impact...

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