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FDANovember 13, 2015device

Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.

What to do

FDA enforcement status: Terminated

Brands named

sterilmed

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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