BEUDAMED
    FDA Recall 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 · Initiated December 27, 2019

    Recall

    Recall Number
    Z-0815-2020
    Event Number
    84560
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    GBO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 27, 2019
    Terminated
    November 23, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    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.

    Action

    On December 27, 2019, the firm sent Urgent Medical Device Recall letters to affected customers, advising them of the recalled products. Customers were asked to take the following actions: 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected].

    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