FDA-Device2017-05-24Class II
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.
Vortran Medical Technology 1, Inc
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.
Sold states
CA, MS, FL
Affected count
35 cases (10 each)
Manufactured in
21 Goldenland Court Ste 100, Sacramento, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2091-2017Don't want to check this manually?
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