Z-2249-2023 Class II Ongoing
FDA device recall Z-2249-2023 was initiated by Creganna Medical Devices on June 22, 2023 and is designated Class II. Reason for recall: Three lots of product may be labeled with an incorrect expiration day The recall status is ongoing. Affected quantity: 194 units.
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