Recall Z-0606-03 ยท LID
Integra LifeSciences Corp
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
| Date | Mar 5, 2003 (initiated Dec 16, 2002) |
| Status | Terminated |
| Reason | The check valve in the patient line may stick in the closed position. |
| Root cause | Other |
| Action | Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx. |
| Quantity | 8952 |
| Distribution | The affected products have been distributed to hospitals, distributors, and Integra Sales Representatives. There are 202 direct hospital customers, 5 foreign distributors, and 1 wholesaler. Government distribution include the National Institute of Health in Bethesda, MD and 9 Veterans Administrati |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910853 | GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET Cordis Corp., Apr 24, 1991 |