Reported Sep 12, 2012 · Terminated
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is…
Newport Medical Instruments Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Newport Medical Instruments Inc · 1620 Sunflower Ave · Costa Mesa, CA · 92626-1513
Is this the product you have?
- Newport HT70 and HT70 Plus Ventilators
- Model NumberHT70 and HT70 Plus
- Product UsageThe HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications
- Lot codes and dates
- Model NumberHT70 and HT70 Plus
- Serial numbers
N12HT700514226 to N12HT700514231N12HT700514233 to N12HT700514236N12HT700514238 to N12HT700614280N12HT700614282 to N12HT700614299N12HT700614301 to N12HT700614309N12HT720410266 to N12HT720410268N12HT720410271N12HT720410273N12HT720410282N12HT720410283N12HT720410286N12HT720410288N12HT720410289N12HT720410290N12HT720410294 to N12HT720510300N12HT720510302N12HT720510322 to N12HT720510330N12HT720510332 to N12HT720510344
- Amount recalled
- 72
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Using this product could cause serious injury, illness or death — stop using it now.
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