Z-0048-04

Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports...

Name: Z-0048-04 Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports...
Creator: Wilson-Cook Medical Inc
Published: 2003-10-08
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2003-10-08 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc began a recall of Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable... on 2003-10-08. The reason FDA records is "Product may be packaged with an incorrect instructions for use (IFU) booklet". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0048-04
Status: Terminated
Initiated: 2003-10-08
Posted: 2003-10-22
Terminated: 2004-11-10
Recalling firm: Wilson-Cook Medical Inc.
Product: Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable Single use only, Rx Only. Cook, Wilson-Cook Medicl GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Product code: FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Reason for recall: Product may be packaged with an incorrect instructions for use (IFU) booklet.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 9 pieces
Distribution: The product was distributed to Hospitals located in CA, NC, PA, and WI.
Product codes and lots: Catalog # CDSB-10, Lot #1589467

Product code FEG

K900035Class IIWilson-Cook Colon Decompression SetWilson-Cook Medical, Inc. / cleared 1990-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)