BEUDAMED
    FDA Recall Terminated

    Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.

    Recall: Z-1367-2021 · Initiated March 2, 2021

    Recall

    Recall Number
    Z-1367-2021
    Event Number
    87504
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    3000204839
    Product Code
    MWS
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 2, 2021
    Terminated
    November 5, 2021
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    Description

    Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.

    Reason

    There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

    Action

    A customer notification letter will be issued on 03/15/2021 by 2-day FedEx mailing to all (8 total) end users who have received affected product. Terumo CVS will provide a replacement device concurrent with the mailing. Customers will be advised to remove the affected product from use and to return product to Terumo CVS using the instructions provided in the customer letter.

    Distribution

    US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.

    Quantity

    12