FDA Medical Device Recalls (openFDA)
Codman & Shurtleff, Inc.: Codman External Drainage System 3 (EDS 3) CSF Without Ventricular Catheter Catalog Number: 82-1731
- Recall number
- Z-1534-06
- Recalling firm
- Codman & Shurtleff, Inc.
- Product
- Codman External Drainage System 3 (EDS 3) CSF Without Ventricular Catheter Catalog Number: 82-1731
- Status
- Terminated
- Initiated
- 2006-08-04
- Posted
- 2006-09-29
- Terminated
- 2015-04-16
- 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.
- Lot, serial or model codes
- Lot Number: CGGCVB
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3002947440
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28