BEUDAMED
    FDA Recall Terminated

    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).

    Recall: Z-2851-2016 · Initiated August 25, 2016

    Recall

    Recall Number
    Z-2851-2016
    Event Number
    75094
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    MQL
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    August 25, 2016
    Posted
    September 20, 2016
    Terminated
    February 1, 2017
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).

    Reason

    Products contain international package insert and not the correct USA package insert

    Action

    CooperSurgical sent an Advisory Notice dated August 25, 2016, to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. The advisory notification asked customers to replace the previously inserted incorrect Instructions for use (IFU) with the correct IFU sent with the advisory notification. For questions regarding this recall call 203-601-5200.

    Distribution

    Nationwide Distribution to CA, GA, and NY

    Quantity

    4 units