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

Recall Z-0630-2014 — Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE

U.S. FDA — Device Enforcement · United States · 2013-12-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0630-2014
Date of alert
2013-12-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Instruments Div. of Stryker Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50731155
Reported risk: The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump.
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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