Recall Z-0774-2019 ยท FFF Cover, Biopsy Forceps
Wilson-Cook Medical Inc.
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
| Date | Dec 18, 2018 |
| Status | Terminated |
| Reason | The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S). |
| Root cause | Error in labeling |
| Action | The firm initiated the recall by letter in Europe on 18-December-2018 and 20-December-2018. The notices were sent in Japan today, 21-December-2018. The letter requested recall to the user level and return of the affected product. |
| Quantity | 8 units |
| Distribution | France, Ireland, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.