BEUDAMED
    FDA Enforcement Class II Terminated

    16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

    Recall: Z-0757-2019 · Reported January 30, 2019

    Enforcement

    Recall Number
    Z-0757-2019
    Event ID
    81873
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fetzer Medical GmbH & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 30, 2019
    Initiation Date
    December 28, 2018
    Classification Date
    January 18, 2019
    Termination Date
    September 17, 2020
    Address
    Unter Buchsteig 5, N/A, Tuttlingen, N/A, N/A, Germany

    Description

    16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

    Reason

    The firm had a report of doctors being unable to pull the obstetric forceps apart.

    Code Info

    Lot Number 18800612

    Distribution

    US Distribution to states of: IL and VA.

    Quantity

    10 units