Codman & Shurtleff, Inc.
Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730
| Date | Sep 29, 2006 (initiated Aug 4, 2006) |
| Status | Terminated |
| Reason | Sterility of device is compromised due to package seal defects |
| Root cause | Other |
| Action | Codman initiated the recall on 8/04/06 by telephone with formal follow-up fax. |
| Quantity | 15 units |
| Distribution | Class II Recall - Nationwide distribution ---- including states of FL, NC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954021 | EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) Johnson & Johnson Professionals, Inc., Oct 24, 1995 |