FDA recall Z-1270-2022
Volcano Corp · Class II · device
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Reason for recall
Due to a potential failed sterilization process.
Distribution
U.S.: WA and WI O.U.S.: Canada
Key facts
- Status
- Terminated
- Initiation date
- 2022-05-16
- Report date
- 2022-06-22
- Termination date
- 2024-12-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- San Diego, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1270-2022