FDAFDA · Food and drugs·Recall number Z-0257-2013
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Published November 14, 2012 · Recall initiated: July 5, 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
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kimberly-Clark Corporation
- Distributor
- Nationwide Distribution
- Lot
- Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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