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

Recall Z-2762-2015 — XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed

U.S. FDA — Device Enforcement · United States · 2015-08-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2762-2015
Date of alert: 2015-08-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Revmedx Inc
Product category: device
Product type: Devices

Reported risk: The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.

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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