BEUDAMED
    FDA Enforcement Class II Terminated

    Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC

    Recall: Z-0815-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0815-2020
    Event ID
    84560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2020
    Initiation Date
    December 27, 2019
    Classification Date
    January 16, 2020
    Termination Date
    November 23, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC

    Reason

    Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

    Code Info

    9799196 9909433 9909435 NS9915808 9796032 9797075 9803175 9806067 9903048 9904465 9904469 9908750 9912303 9916724 9785599 9785601 9791159 9796027 9813313 9824161 9825417 9828101 9828889 9830401 9830764 9833563 9836323 9839119 9844952 9846005 9846008 9913052 9915805 9791163X 9792493X NS9813314 NS9828892 NS9834712

    Distribution

    Nationwide domestic distribution. Foreign distribution to Australia, Belgium, Canada, China, Colombia, Denmark, France, Germany, Italy, Korea, Netherlands, New Zealand, Peru, Russia, Spain, Sweden, and United Kingdom.

    Quantity

    1604