BEUDAMED
    FDA Recall 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 · Initiated October 6, 2017

    Recall

    Recall Number
    Z-1131-2018
    Event Number
    79213
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    KNG
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 6, 2017
    Terminated
    February 6, 2020
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    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

    Action

    CooperSurgical sent an Urgent Medical Device Recall letter dated October 6, 2017 to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for replacement. If you have any further questions please feel free to contact me at 203.601.5200.

    Distribution

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

    Quantity

    13 units