The Recall Desk

FDA (Devices) recall action 77072

Vortran Medical Technology 1, Inc recalled 2 products on 2017-05-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-05-24
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2017-05-24

    Vortran Automatic Resuscitator Recalled Due to Reverse-Threaded Oxygen Connector

    Vortran is recalling 14 cases of VARPlus Automatic Resuscitators because the oxygen tubing connector was assembled in reverse, preventing it from being screwed on.

    Product
    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.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2017-05-24

    Vortran VARPlus Automatic Resuscitator Recalled Due to Connector Assembly Error

    Vortran is recalling 35 cases of VARPlus Automatic Resuscitators because a connector was assembled in the reverse direction, preventing it from screwing onto the oxygen tubing.

    Product
    VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; 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.
    Category
    Distribution
    3 states