External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
FDA device recall Z-0606-03 · posted 2003-03-05 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp
- Reason for recall
- The check valve in the patient line may stick in the closed position.
- Action taken
- Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.
- Root cause
- Other
- Status
- Terminated
- Product code
- LID
- Quantity affected
- 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
- Date initiated
- 2002-12-16
- Date posted
- 2003-03-05
- Date terminated
- 2003-10-31
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET (K910853) | Cordis Corp. | 1991-04-24 |