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

Recall Z-0228-2016 — MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides

U.S. FDA — Device Enforcement · Canada · 2015-08-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0228-2016
Date of alert: 2015-08-31
Country / jurisdiction: Canada
Risk level: Class II
Risk type: recall
Brand: Pyng Medical Corporation
Product category: device
Product type: Devices

Reported risk: Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging.

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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