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U.S. Department of Health and Human Services

Class 2 Device Recall Newport HT70 Ventilator

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 Class 2 Recall
Newport HT70 Ventilator
see related information
Date Posted June 02, 2011
Recall Status1 Terminated on June 03, 2011
Recall Number Z-2406-2011
Recall Event ID 58619
Premarket Notification
510(K) Number
K090888 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 ventilator is suitable for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications.
Code Information Serial Numbers: N10HT700810209 - N10HT700810218, N10HT700910219-N10HT700910225
Recalling Firm/
Manufacturer
Newport Medical Instruments Inc
1620 Sunflower Ave
Costa Mesa, California 92626-1513
Manufacturer Reason
for Recall
The recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place. These cords are fully functional as supplied. However, the cord can be easily disconnected. If the cord is disconnected, the HT70 will alert the user with a power di
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Newport Medical sent an PRODUCT NOTICE LETTER, dated September 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to discard the original cord and only use the replacement cord to avoid unintentional disconnection of the power cord. Each affected Customer was sent a replacement cord. Customers with any questions regarding the Product Notice were instructed to contact the Technical Support Department at (800) 451-3111.
Quantity in Commerce 22 units total
Distribution Worldwide Distribution--USA (nationwide) including the states of MA, PA, OH, IA and Puerto Rico and the countries of Colombia, UAE, Hong Kong, Hungary, India, Japan, Nepal, China, Philippines, Singapore and South Africa.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.
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