Recall Z-1874-2017— Newport Medical Instruments Inc

Name: FDA recall Z-1874-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-30

Class I · Terminated

Class I FDA medical device recall by Newport Medical Instruments Inc, initiated 2017-03-30, terminated 2020-07-18. It names 2 FDA 510(k) clearances: K111146, K090888. Product: Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The 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.. Reason: 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..

Recalling firm: Newport Medical Instruments Inc
Classification: Class I
Status: Terminated
Initiated: 2017-03-30
Terminated: 2020-07-18
Firm location: Costa Mesa, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K111146 — NEWPORT HT70 VENTILATORNewport Medical Instruments, Inc.·cleared 2011-12-01
K090888 — NEWPORT HT70 FAMILY OF VENTILATORSNewport Medical Instruments, Inc.·cleared 2009-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The 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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.