Device product
MicroCool Breathable Gown with Towels, X-Larg, X-Long, 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-0258-2013
Product summary
- Event
- Event 63598
- Status
- Terminated
- Classification
- Class II
- Quantity
- 933 ((30 units per case)
- Official record key
device-enforcement:Z-0258-2013
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 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175***
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.