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

Recall Z-0138-2015 — Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing proc

U.S. FDA — Device Enforcement · United States · 2014-09-08 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0138-2015
Date of alert: 2014-09-08
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Coloplast Manufacturing US, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0463001400

Reported risk: Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.

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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