BEUDAMED
    FDA Recall Terminated

    Milex Arcing Diaphragm Size 95; Model Number: MXWS95

    Recall: Z-1054-2016 · Initiated February 16, 2016

    Recall

    Recall Number
    Z-1054-2016
    Event Number
    73329
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HDW
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    February 16, 2016
    Posted
    March 4, 2016
    Terminated
    March 29, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Milex Arcing Diaphragm Size 95; Model Number: MXWS95

    Reason

    The products have been identified to contain an incorrect size Diaphragm.

    Action

    Cooper Surgical sent an "Urgent - Medical Device Recall" letter dated February 16, 2016, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt form for replacement. For further questions, please call (203) 601-9818.

    Distribution

    US Distribution to the states of : OR and NY

    Quantity

    2 units