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

Recall Z-0324-2017 — Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to cre

U.S. FDA — Device Enforcement · United States · 2016-09-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0324-2017
Date of alert: 2016-09-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Sustainability Solutions
Product category: device
Product type: Devices

Reported risk: Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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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