Reported May 10, 2017 · Terminated
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators 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 Medical HT70 and HT70- Plus Ventilators
- Rx Only Product UsageThe Newport HT70 family of ventilators 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 Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport 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
- All Newport Medical HT70 and HT70- Plus Ventilators
- Amount recalled
- 12,966
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.
Using this product could cause serious injury, illness or death — stop using it now.
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