FDAApril 20, 2017device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
vortran medical technology 1vortranvortran medical
Recall history
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