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

Recall Z-0404-2016 — Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

U.S. FDA — Device Enforcement · United States · 2015-11-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0404-2016
Date of alert
2015-11-13
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 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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