BEUDAMED
    FDA Recall Terminated

    Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB, N830SB, N840SB, N920SB, N930SB, N940SB, N1020SB, N1030SB, N1040SB only. This recall also affects Cordis PRECISE Nitinol Stent System, not distributed in the United States, Catalog numbers, N920SC, N930SC, N940SC, N1020SC, N1030SC and N1040SC only.

    Recall: Z-0323-03 · Initiated November 7, 2002

    Recall

    Recall Number
    Z-0323-03
    Event Number
    25043
    Firm
    Cordis Corporation
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2002
    Posted
    December 5, 2002
    Terminated
    November 25, 2008
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014

    Description

    Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB, N830SB, N840SB, N920SB, N930SB, N940SB, N1020SB, N1030SB, N1040SB only. This recall also affects Cordis PRECISE Nitinol Stent System, not distributed in the United States, Catalog numbers, N920SC, N930SC, N940SC, N1020SC, N1030SC and N1040SC only.

    Reason

    Field complaints of marker band spacing being out of spec.

    Action

    The firm sent, via First Class Mail, a Recall notification Letter with Response Card on 11/7/02. The letter asks for response from the user accounts and for return of product. The letter includes a UPS label for return of product. Non-responders will be recontacted as part of the firm''s effectiveness checks.

    Distribution

    Product was distributed to 620 hospital accounts nationwide. The firm did not provide information on international accounts. This info was requested from firm and RES will be updated when available.

    Quantity

    10,468