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

Recall Z-0256-2023 — 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape

U.S. FDA — Device Enforcement · United States · 2022-10-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0256-2023
Date of alert
2022-10-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
3M Healthcare Business
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50707387497410
Reported risk: During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.
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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