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Respironics

This article was originally published in The Gray Sheet

Executive Summary

Taking steps to "enhance its manufacturing systems and procedures" at its Plum Borough, Pennsylvania facility in response to an FDA 483 report of adverse inspectional observations, the company says in an Oct. 7 press release. The Plum Borough facility is used primarily to manufacture the company's BagEasy manual resuscitator. Respironics also announced a recall of its 12 volt battery adapter cable for apnea monitors following receipt of "a very limited number of reports of the cable overheating." The company has sold roughly 1,700 of the cables, which retail for approximately $25, since their introduction in 1991. The cables are manufactured for Respironics by an outside vendor.
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