Recall Z-0955-2023 ยท NEY System, Ablation, Microwave And Accessories
Covidien, LLC
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
| Date | Jan 12, 2023 (initiated Nov 23, 2022) |
| Status | Open, Classified |
| Reason | The product is labeled with the incorrect expiration date. |
| Root cause | Process control |
| Action | On about 11/23/2022, the single customer was notified with an "URGENT: MEDICAL DEVICE RECALL" letter via visit. The letter instructed the consignee to immediately identify, segregate, and quarantine affected products within your inventory, pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred, and to contact Medtronic to return affected product. Additionally. the consignee was instructed to complete and return the customer confirmation form even if you do not have any affected units. |
| Quantity | 21 units |
| Distribution | Foreign Distribution: Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.