Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730
FDA device recall Z-1533-06 · posted 2006-09-29 · Terminated
Recall details
- Recalling firm
- Codman & Shurtleff, Inc.
- Reason for recall
- Sterility of device is compromised due to package seal defects
- Action taken
- Codman initiated the recall on 8/04/06 by telephone with formal follow-up fax.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 15 units
- Distribution
- Class II Recall - Nationwide distribution ---- including states of FL, NC, TN, and TX.
- Date initiated
- 2006-08-04
- Date posted
- 2006-09-29
- Date terminated
- 2015-04-16
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) (K954021) | Johnson & Johnson Professionals, Inc. | 1995-10-24 |