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.
FDA Recall Z-0048-04 · Posted 2003-10-22
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Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFEG
Date Initiated2003-10-08
Date Terminated2004-11-10
Product Quantity9 pieces
Reason for Recall
Product may be packaged with an incorrect instructions for use (IFU) booklet.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed to Hospitals located in CA, NC, PA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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