BEUDAMED
    FDA Recall Terminated

    Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safety wire / guidewire placement. The "ACMI" Dual Lumen Catheter is a radiopaque ureteral catheter.

    Recall: Z-2226-2008 · Initiated June 25, 2008

    Recall

    Recall Number
    Z-2226-2008
    Event Number
    48691
    Firm
    Gyrus ACMI Corporation
    FEI Number
    3003790304
    Product Code
    EYB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 25, 2008
    Posted
    September 16, 2008
    Terminated
    May 7, 2012
    Address
    136 Turnpike Rd, Southborough, MA, 01772-2118

    Description

    Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safety wire / guidewire placement. The "ACMI" Dual Lumen Catheter is a radiopaque ureteral catheter.

    Reason

    Particulate matter in the catheter

    Action

    Gyrus initiated a recall by letter dated 6/ 25 /08. An updated letter issued July 9, 2008 which supersedes the previous letter. The July 9th letter updates the lot numbers affected in the recall. A reply form request was sent to consignees informing them of the problem and asking them to obtain a RMA and return the product. They are also requested to FAX back a reply form so that the response can be tracked. For assistance, please contact Gyrus ACMI at 1-888-524-7266.

    Distribution

    Nationwide Foreign: Canada, UK, Netherlands, Spain, Italy, Sweden, France, Portugal, Ireland, , Brazil, Australia, South Africa, and Turkey

    Quantity

    6820 units