Zimmer recalled over sterility concerns

Recall date

November 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-0404-2016

FDA classification

Class II

Brand / firm

STERILMED, INC.

Sold / distributed

US: Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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