Recall Z-0048-04 ยท FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Wilson-Cook Medical Inc
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.
| Date | Oct 22, 2003 (initiated Oct 8, 2003) |
| Status | Terminated |
| Reason | Product may be packaged with an incorrect instructions for use (IFU) booklet. |
| 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 | 9 pieces |
| Distribution | The product was distributed to Hospitals located in CA, NC, PA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900035 | WILSON-COOK COLON DECOMPRESSION SET Wilson-Cook Medical, Inc., Mar 7, 1990 |