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

Recall Z-1134-2022 — SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

U.S. FDA — Device Enforcement · United States · 2022-04-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1134-2022
Date of alert
2022-04-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ConvaTec, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00768455106189
Reported risk: Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
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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