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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 Device Recall Newport HT70 Ventilator see related information
Date Initiated by Firm September 20, 2010
Date Posted June 02, 2011
Recall Status1 Terminated 3 on June 03, 2011
Recall Number Z-2406-2011
Recall Event ID 58619
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 CA 92626-1513
For Additional Information Contact
714-427-5811 Ext. 344
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.
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