BEUDAMED
    FDA Enforcement Class II Terminated

    Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use

    Recall: Z-0173-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0173-2019
    Event ID
    81052
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    August 24, 2018
    Classification Date
    October 17, 2018
    Termination Date
    April 29, 2020
    Address
    3175 Staley Rd, N/A, Grand Island, NY, 14072-2028, United States

    Description

    Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use

    Reason

    Leaky bottles due to a defect in the bottle cap compromising the sterility of the product

    Code Info

    Lot# 1967697 Exp. Date 30-Jun-2019. (UDI 10190302001823)

    Distribution

    Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan

    Quantity

    41 units