Recall Z-2249-2023 ยท DYB Introducer, Catheter
Creganna Medical Devices
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
| Date | Jul 28, 2023 (initiated Jun 22, 2023) |
| Status | Open, Classified |
| Reason | Three lots of product may be labeled with an incorrect expiration day |
| Root cause | Process control |
| Action | 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. |
| Quantity | 194 units |
| Distribution | US Nationwide distribution in the state of AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle Creganna Medical Aslo Business AS Cregganna Tactx Medical, Jul 21, 2016 |