BEUDAMED
    FDA Enforcement Class II Terminated

    Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

    Recall: Z-1131-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1131-2018
    Event ID
    79213
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    October 6, 2017
    Classification Date
    March 19, 2018
    Termination Date
    February 6, 2020
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

    Reason

    The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

    Code Info

    SIN 2017070001 SIN 2017070008 SIN 2017070002 SIN 2017070009 SIN 2017070003 SIN 2017070010 SIN 2017070004 SIN 2017070011 SIN 2017070005 SIN 2017070012 SIN 2017070006 SIN 2017070013 SIN 2017070007

    Distribution

    Worldwide Distribution - US Nationwide and the countries of ( Canada and England)

    Quantity

    13 units