Recall Z-0008-04 ยท DWS Instruments, Surgical, Cardiovascular
Rultract Inc
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
| Date | Oct 15, 2003 (initiated Sep 18, 2003) |
| Status | Terminated |
| Reason | Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure. |
| Root cause | Other |
| Action | The firm notified their affected consignees by letter on 9/18/2003. |
| Quantity | 2,718 units |
| Distribution | The device was distributed to end-users located nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.