Device product
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Z-1266-2016
Product summary
- Firm
- PMBS, LLC
- Event
- Event 73157
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58 units
- Official record key
device-enforcement:Z-1266-2016
Official wording
Reason: Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Code information: ALL distributed S.C.O.R.E.S. units are affected.
Distribution pattern: FL, GA, MN, NY, OH, OR SC, and TN
Derived failure modes
-
Sterility assurance
compromised sterility