BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.

    Recall: Z-1106-04 · Initiated June 25, 2004

    Recall

    Recall Number
    Z-1106-04
    Event Number
    29486
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    GBO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 25, 2004
    Posted
    July 20, 2004
    Terminated
    August 23, 2004
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.

    Reason

    Mislabeled as to size; 10FR are labeled as 8FR.

    Action

    The firm hand delivered the recall notification to the consignee hospital on 6/30/04. Product at the customer have been relabeled by the firm.

    Distribution

    Missouri.