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

Recall Z-0592-2020 — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of bl

U.S. FDA — Device Enforcement · United States · 2019-11-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0592-2020
Date of alert: 2019-11-06
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): 37613154599258

Reported risk: There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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