BEUDAMED
    FDA Recall Terminated

    URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500 Intended use: Collector urine from male patients (and accessories) for indwelling catheter

    Recall: Z-2393-2011 · Initiated April 29, 2011

    Recall

    Recall Number
    Z-2393-2011
    Event Number
    58665
    FEI Number
    1282497
    Product Code
    KNX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 29, 2011
    Posted
    May 27, 2011
    Terminated
    May 29, 2015
    Address
    LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113

    Description

    URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500 Intended use: Collector urine from male patients (and accessories) for indwelling catheter

    Reason

    A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination

    Action

    The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated April 29, 2011 to its customers via US Postal Service. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the product, place in quarantine, and return any inventory. Distributors are requested to notify their customers. All customers are required to respond to the notice regardless of remaining inventory. Responses will be tracked for follow-up and effectiveness checks. For Customer Service questions regarding the recall please telephone: 1-800-962-9888 option 1 (weekdays, 8am to 6:30pm Eastern) and email to: [email protected]. Should you have any medical questions concerning this recall, please call 508-261-6393.

    Distribution

    Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.

    Quantity

    52128 units