RecallDepth

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.

Company
Wilson-Cook Medical Inc
Recall Initiated
October 8, 2003
Posted
October 22, 2003
Terminated
November 10, 2004
Recall Number
Z-0048-04
Quantity
9 pieces
Firm Location
Winston-Salem, NC

Reason for Recall

Product may be packaged with an incorrect instructions for use (IFU) booklet.

Distribution

The product was distributed to Hospitals located in CA, NC, PA, and WI.

Lot / Code Info

Catalog # CDSB-10, Lot #1589467

Root Cause

Other

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.

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