Recall Z-0420-2022 ยท DYB Introducer, Catheter
Abbott
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
| Date | Nov 16, 2021 |
| Status | Terminated |
| Reason | As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by telephone on 16 NOV 2021 followed by a letter emailed on 18 NOV 2021. The letter explained the problem and requested the return of the affected devices. |
| Quantity | 10 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.