Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
FDA device recall Z-2249-2023 · posted 2023-07-28 · Open, Classified
Recall details
- Recalling firm
- Creganna Medical Devices
- Reason for recall
- Three lots of product may be labeled with an incorrect expiration day
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 194 units
- Distribution
- US Nationwide distribution in the state of AZ.
- Date initiated
- 2023-06-22
- Date posted
- 2023-07-28
- Location
- Mweeloon Galway, Ireland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle (K152913) | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2016-07-21 |