BEUDAMED
    FDA Recall Terminated

    Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411

    Recall: Z-0714-2008 · Initiated November 12, 2007

    Recall

    Recall Number
    Z-0714-2008
    Event Number
    45907
    Firm
    Coloplast Corp
    FEI Number
    2125050
    Product Code
    FQH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 12, 2007
    Posted
    April 3, 2008
    Terminated
    November 4, 2008
    Address
    1525 W River Rd, Minneapolis, MN, 55411-3430

    Description

    Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411

    Reason

    Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.

    Action

    Coloplast sent customers an "Urgent: Recall Notification" letter on 11/12/07. The letter described that the sterilization of the products was not performed according to ISO 11135 standard. The notification requested the customers to return the product immediately and to send a fax or contact the company via email in regard to inventory at hand. A phone script for distributors also included an advice to discontinue dispensing the product and to fax or email in regard to inventory at hand.

    Distribution

    Nationwide, including Puerto Rico.

    Quantity

    559