BEUDAMED
    FDA Recall Terminated

    Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use

    Recall: Z-3212-2018 · Initiated May 3, 2018

    Recall

    Recall Number
    Z-3212-2018
    Event Number
    80657
    Firm
    Medtronic Neurosurgery
    FEI Number
    3015531529
    Product Code
    HBO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 3, 2018
    Terminated
    August 30, 2022
    Address
    125 Cremona Dr, Goleta, CA, 93117-3083

    Description

    Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use

    Reason

    The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.

    Action

    Consignee Notification URGENT: MEDICAL DEVICE RECALL has been sent to US customers on 03-May-2018. For foreign customers, the Consignee Notification is in process. The Consignee letter informs customers of the situation and the required course of action which includes: 1. Cease use of the listed product 2. Account for number of product units used or discarded and return any units by completing the attached individualized Customer Confirmation form provided. Please follow the instructions described in the Customer Confirmation form. 3. Clinicians and their Patients who may have received the listed devices should monitor the patients condition to determine if there are any signs of infection. If this is the case, the patient should seek medical attention immediately to treat the infection. In addition, the Notification Letter should be provided to all those who need to be aware of this matter within your organization or to any organization where the potentially affected products may have been transferred. Fax the Customer Acknowledgement Response Form to Medtronic Neurosurgery at (805) 571-8787 or take a clear picture or scan of signed form and email it to [email protected] with "Magazine Recall" in the subject line.

    Distribution

    Domestic: AL, AZ, AR, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, LA, MD, MI, MN, MS, MO, NB, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY OUS: Australia, Germany, Kenya, Russian Federation, South Africa

    Quantity

    2616