Device product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Z-1270-2022
Product summary
- Firm
- Volcano Corp
- Event
- Event 90292
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 devices
- Official record key
device-enforcement:Z-1270-2022
Official wording
Reason: Due to a potential failed sterilization process.
Code information: Model Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Numbers: 37583 37586 37590 37598 37612 37648 37655 37692 37694 37709 37719
Distribution pattern: U.S.: WA and WI O.U.S.: Canada
Derived failure modes
-
Sterility assurance
failed sterilization