BEUDAMED
    FDA Recall Open, Classified

    Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

    Recall: Z-1348-2023 · Initiated February 13, 2023

    Recall

    Recall Number
    Z-1348-2023
    Event Number
    91794
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    MQL
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    February 13, 2023
    Posted
    April 6, 2023
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

    Reason

    It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.

    Action

    An URGENT: VOLUNTARY MEDIA RECALL dated 1/26/23 was sent to customers. Actions to be Taken: For both CUSTOMERS and DISTRIBUTORS: " Inspect your stock for the Product from this lot. Lot information can be found on the box and bottle labeling. o If found, quarantine, and discontinue use of the Product from this lot immediately. o Please complete and return the appropriate enclosed Acknowledgment Form (even if you do not have the specific lot remaining in stock) to initiate our recall return process. Credit will be applied to your account to reorder replacement product, as per our recall process, with no additional cost to you or your facilities. o The form can be returned to CooperSurgical via email at [email protected] or via fax at +1.203.601.9870 Please feel free to contact your local account manager or contact us at +1-203-601-5200 Monday Friday 09:00 17:00 EST, and follow the phone prompt to enter the ext. 3300 or via email at [email protected]. If affected Product has been distributed to customers, please select one of the following options: " I have identified and notified all customers to whom the affected Product may have been distributed. " I am providing a list of all customers to whom affected Product may have been distributed along with their contact information.

    Distribution

    Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.

    Quantity

    190 units