FDA recall Z-2249-2023
Creganna Medical Devices · Class II · device
Product
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Reason for recall
Three lots of product may be labeled with an incorrect expiration day
Distribution
US Nationwide distribution in the state of AZ.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-06-22
- Report date
- 2023-08-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Galway, N/A, Ireland
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2249-2023