Z-1270-2022 Class II Terminated
FDA device recall Z-1270-2022 was initiated by Volcano Corp on May 16, 2022 and is designated Class II. Reason for recall: Due to a potential failed sterilization process. The recall status is terminated (terminated December 23, 2024). Affected quantity: 11 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2022
- Initiation Date
- May 16, 2022
- Termination Date
- December 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 devices
Product Description
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Reason for Recall
Due to a potential failed sterilization process.
Distribution Pattern
U.S.: WA and WI O.U.S.: Canada
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