Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 (casepac — recall Z-2819-2015

U.S. FDA — Device Enforcement · United States · 2015-08-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2819-2015
Date of alert
2015-08-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
STERILMED, INC.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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