Device evidence

device-recall:cfres:154926

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.

Official recall number

Z-2092-2017

Evidence summary

Product code: BTL
Recall status: Terminated
Event initiated: April 20, 2017
Root cause: Process control
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-2092-2017