BEUDAMED
    FDA Recall Terminated

    EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.

    Recall: Z-0079-04 · Initiated April 23, 2002

    Recall

    Recall Number
    Z-0079-04
    Event Number
    27461
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FCG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 23, 2002
    Posted
    October 31, 2003
    Terminated
    December 4, 2003
    Address
    4900 Bethania Station Rd, &, Winston-Salem, NC, 27105

    Description

    EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.

    Reason

    There is a possibility that the affected devices would not capture a biopsy during a procedure.

    Action

    On April 24, 2002 all field representatives were notified via email and all international accounts via fax. Consignees were advised to quarantine all affected product in their possession and to give the product to their Territory Manager for return. Consignees were urged to complete the bottom portion of the letter and return it via the Territory Manager to Wilson-Cook Medical.

    Distribution

    Units were distributed to medical facilities nationwide, UK and Israel

    Quantity

    129 units