Recall Z-1423-05 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve.
| Date | Aug 30, 2005 (initiated Jul 11, 2005) |
| Status | Terminated |
| Reason | Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle. |
| Root cause | Other |
| Action | A customer communication was sent by first class mail on 7/26/05, advising all consignees of the problem. The letter asks each customer to immediately examine their inventory for affected lot numbers, return product from affected lots using enclosed label and packing slip, and to notify all of their affected customers to alert them to the situation. |
| Quantity | 641200 eaches |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990188 | INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 Intuitive Surgical, Inc., Apr 1, 1999 |