Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard
FDA device recall Z-0048-04 · posted 2003-10-22 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- Product may be packaged with an incorrect instructions for use (IFU) booklet.
- Action taken
- Recall notification was sent via email to Wilson-Cook, sales representatives on 10/08/2003 for personal delivery to the affected accounts. Consignees were advised to quarantine and return all affected product via Federal Express (using Wilson-Cook Medical account) to the recalling firm. A verification form was included at the bottom portion of the notice to be returned with the affected product or faxed to Wilson-Cook. Replacement product or account credit will be provided upon receipt of any affected devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- FEG
- Quantity affected
- 9 pieces
- Distribution
- The product was distributed to Hospitals located in CA, NC, PA, and WI.
- Date initiated
- 2003-10-08
- Date posted
- 2003-10-22
- Date terminated
- 2004-11-10
- Location
- Winston-Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WILSON-COOK COLON DECOMPRESSION SET (K900035) | Wilson-Cook Medical, Inc. | 1990-03-07 |