BEUDAMED
    FDA Recall 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 · Initiated April 20, 2017

    Recall

    Recall Number
    Z-2092-2017
    Event Number
    77072
    Firm
    Vortran Medical Technology 1, Inc
    FEI Number
    1000307109
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 20, 2017
    Posted
    April 25, 2017
    Terminated
    October 17, 2017
    Address
    21 Goldenland Court, Ste 100, Sacramento, CA, 95834-2427

    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.

    Action

    Medical Device Recall letters were sent on April 20, 2017. Letters explained the reason for recall and listed the specific lots sent to each distributor along with dates, PO numbers and quantity. Vortran Medical asks that each distributor provide a list of customers who received the affected product so that they can notify them directly of the recall.

    Distribution

    CA, MS, FL

    Quantity

    14 cases (10 each)