BEUDAMED
    FDA Enforcement Class III 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 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2851-2016
    Event ID
    75094
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    August 25, 2016
    Classification Date
    September 20, 2016
    Termination Date
    February 1, 2017
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    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

    Code Info

    Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016

    Distribution

    Nationwide Distribution to CA, GA, and NY

    Quantity

    4 units