BEUDAMED
    FDA Enforcement Class II Terminated

    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    Recall: Z-2092-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2092-2017
    Event ID
    77072
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vortran Medical Technology 1, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    April 20, 2017
    Classification Date
    May 13, 2017
    Termination Date
    October 17, 2017
    Address
    21 Goldenland Court Ste 100, Sacramento, CA, 95834-2427, United States

    Description

    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    Reason

    Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.

    Code Info

    Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.

    Distribution

    CA, MS, FL

    Quantity

    14 cases (10 each)