BEUDAMED
    FDA Recall Terminated

    MediCult Vitrification Cooling Media, Model Number 12284001F

    Recall: Z-0100-2021 · Initiated September 8, 2020

    Recall

    Recall Number
    Z-0100-2021
    Event Number
    86479
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    MQL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 8, 2020
    Terminated
    January 11, 2021
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    MediCult Vitrification Cooling Media, Model Number 12284001F

    Reason

    There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

    Action

    URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE letters dated 9/8/20 were sent to customers. Our records indicate that you have purchased the affected Product from CooperSurgical. The affected Vitrification Medium Product is of the correct formulation and functionally acceptable per quality release specifications and will work as intended in accordance with the accompanying Instructions For Use. Please discontinue use of and quarantine the Products, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Field Safety Notice. The Chinese Food and Drug Administration has been notified of this Field Safety Notice. We sincerely apologize for any inconvenience caused by this Field Safety Notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at +001.203.601.5200 ext. 3300.

    Distribution

    The products were distributed to China.

    Quantity

    531 total boxes