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

Recall Z-0242-2023 — Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

U.S. FDA — Device Enforcement · United States · 2022-09-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0242-2023
Date of alert
2022-09-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Texas Medical Technology Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850022960338
Reported risk: Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric.
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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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.