Vortran Medical Technology 1, Inc recalls VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device i…

Recall date

April 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2092-2017

FDA classification

Class II

Brand / firm

Vortran Medical Technology 1, Inc

Sold / distributed

CA, MS, FL

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.