Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
This recall is currently active, issued July 28, 2023. It was issued by Creganna Medical Devices Parkmore House Mweeloon Galway Ireland.
- Recall Initiated
- June 22, 2023
- Posted
- July 28, 2023
- Recall Number
- Z-2249-2023
- Quantity
- 194 units
- Official Source
- View on FDA website ↗
Reason for Recall
Three lots of product may be labeled with an incorrect expiration day
Distribution
US Nationwide distribution in the state of AZ.
Lot / Code Info
UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
Root Cause
Process control
Action Taken
Creganna Medical notified its sole consignee on 06/22/2023 via email. The notice explained the problem with the product and informed the consignee of their intention to collaboratively conduct a recall. The sole consignee is notifying their customers by letter delivered by FedEX on 06/28/2023. The product is to be returned to the consignee.