Device product
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.
Z-0257-2013
Product summary
- Event
- Event 63598
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89,856 (28 units per case)
- Official record key
device-enforcement:Z-0257-2013
Official wording
Reason: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Code information: Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.