Vortran Medical Technology 1, Inc: Medical Device Recall in 2017 - (Recall #: Z-2092-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: April 20, 2017

Date Posted: May 24, 2017

Recall Number: Z-2092-2017

Event ID: 77072

Reason for Recall:

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.

Status: Terminated

Product Quantity: 14 cases (10 each)

Code Information:

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

Distribution Pattern:

CA, MS, FL

Voluntary or Mandated:

Voluntary: Firm initiated