Recall Z-1297-2022 ยท GBZ Catheter, Cholangiography
Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
| Date | Apr 21, 2022 |
| Status | Open, Classified |
| Reason | Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date |
| Root cause | Under Investigation by firm |
| Action | Getinge issued Urgent Medical Device Removal to consignees via FedEx with Signature Proof of Delivery on 4/21/22. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the Atrium Firm PVC Thoracic Catheter 28French with the REF/LOT number listed in this notice. Should you have any affected product, please remove from area(s) of use. The LOT Number (ME231010) can be found on the product label illustrated. " If you have affected product, you are entitled to a replacement at no cost to your facility. You will re |
| Quantity | 56 cases (560 units / 10 units per case) |
| Distribution | AZ IL KS LA MI NY OH OK TX VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.