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Vortran Medical Technology 1, Inc recalls VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This devic
Recalled May 24, 2017 · FDA recall Z-2092-2017 · Vortran Medical Technology 1
Hazard
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. · FDA Class II
Units
14 cases (10 each)
Sold at
CA, MS, FL
Description
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.
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(s)
Vortran Medical Technology 1, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →