BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0048-04 · Initiated October 8, 2003

    Recall

    Recall Number
    Z-0048-04
    Event Number
    27449
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FEG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 8, 2003
    Posted
    October 22, 2003
    Terminated
    November 10, 2004
    Address
    4900 Bethania Station Rd, &, Winston-Salem, NC, 27105

    Description

    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.

    Reason

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

    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.

    Distribution

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

    Quantity

    9 pieces