FDA Recall
Terminated
Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730
Recall: Z-1533-06
·
Initiated August 4, 2006
Recall
- Recall Number
- Z-1533-06
- Event Number
- 36045
- Firm
- Codman & Shurtleff, Inc.
- FEI Number
- 3002947440
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 4, 2006
- Posted
- September 29, 2006
- Terminated
- April 16, 2015
- Address
- 325 Paramount Drive, Raynham, MA, 02767-5199
Description
Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730
Reason
Sterility of device is compromised due to package seal defects
Action
Codman initiated the recall on 8/04/06 by telephone with formal follow-up fax.
Distribution
Class II Recall - Nationwide distribution ---- including states of FL, NC, TN, and TX.
Quantity
15 units