FDAFDA · Food and drugs·Recall number Z-1858-2012
Hartmann Sterilux Ref 56910000 Sterile Premium 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
Published July 4, 2012 · Recall initiated: May 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hartmann USA, Inc
- Distributor
- Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.
- Lot
- Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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