Z-2406-2011

Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or...

Name: Z-2406-2011 Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or...
Creator: Newport Medical Instruments Inc
Published: 2010-09-20
License: https://open.fda.gov/license/

Newport Medical Instruments, Inc. / initiated 2010-09-20 / Terminated / root cause: supplier

FDA source

Newport Medical Instruments Inc began a recall of Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory... on 2010-09-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2406-2011
Status: Terminated
Initiated: 2010-09-20
Posted: 2011-06-02
Terminated: 2011-06-03
Recalling firm: Newport Medical Instruments, Inc.
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.
Product code: CBK Ventilator, Continuous, Facility Use
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
Root cause tag: supplier
FDA root cause: 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.
Product codes and lots: Serial Numbers: N10HT700810209 - N10HT700810218, N10HT700910219-N10HT700910225

Product code CBK

K090888Class IINewport Ht70 Family of VentilatorsNewport Medical Instruments, Inc. / cleared 2009-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)