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

Recall Z-1857-2012 — Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing

U.S. FDA — Device Enforcement · United States · 2012-05-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1857-2012
Date of alert
2012-05-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hartmann USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
101546391
Reported risk: Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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