BEUDAMED
    FDA Recall Terminated

    APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    Recall: Z-0080-04 · Initiated July 25, 2003

    Recall

    Recall Number
    Z-0080-04
    Event Number
    27462
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 25, 2003
    Posted
    October 31, 2003
    Terminated
    December 4, 2003
    Address
    4900 Bethania Station Rd, &, Winston-Salem, NC, 27105

    Description

    APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    Reason

    The label is missing the Rx Only symbol.

    Action

    The consignee was notified by the sales representative on/about July 29, 2003 via hand delivered letter. The consignee was informed of the recall and was advised to quarantine and return the affected product, via the Territory Manager. The consignee was urged to complete and return the response portion of the letter.

    Distribution

    Product was distributed to one account in IL.

    Quantity

    3 units