Z-0257-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2012
- Initiation Date
- July 5, 2012
- Termination Date
- June 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,856 (28 units per case)
Product Description
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.
Reason for Recall
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Distribution Pattern
Nationwide Distribution
Code Information
Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***