Zimmer recalled over labeling errors

Recall date

August 24, 2015

Source

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

Official notice title

STERILMED, INC. recalls Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number…

Recall number

Z-2819-2015

FDA classification

Class II

Brand / firm

STERILMED, INC.

Sold / distributed

US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.

Why it was recalled

Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.

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, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.