Z-2249-2023 Class II Ongoing

Recalled by Creganna Medical Devices — Galway, N/A

Recall Details

Product Type
Devices
Report Date
August 9, 2023
Initiation Date
June 22, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
194 units

Product Description

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 Pattern

US Nationwide distribution in the state of AZ.

Code Information

UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622