The Recall Desk
HighFDA (Devices)·Z-2092-2017·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for emergency ventilatory support where a defect prevents the device from being connected, creating a risk of harm, but no injuries or illnesses have been reported.

Plain-English summary

Vortran Medical Technology 1, Inc. is recalling 14 cases (10 units each) of the VORTRAN Automatic Resuscitator, VARPlus with Extension Kit, Model PCE-5012. The recall was initiated after a customer complaint reported that the spin-nut-DSS connector on the oxygen tubing was assembled in the reverse direction.

The defect causes the connector to have the wrong thread direction, making it unable to be screwed on. This device is intended for use by properly trained personnel to deliver emergency, short-term, constant flow, pressure cycled ventilatory support. The affected units were distributed in California, Mississippi, and Florida.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any injuries or illnesses associated with the defect.

The recalled product

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.
Manufacturer
Vortran Medical Technology 1, Inc
Category
Medical Device — Respiratory / Ventilatory Support
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Vortran Medical Technology 1, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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