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Newport HT70 and HT70 Plus Ventilators, Model Number: HT70… recallZ-2250-2012 · Newport Medical Instruments Inc · initiated Aug 3, 2012

Class I Terminated All recalls posted in April 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Newport Medical Instruments Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Newport Medical sent an Urgent Field Correction Notice letter dated August 3, 2012 to all affected customers, via DHL and FedEx courier services. The letter identified the affected product, reason for recall and actions to be taken. Customers were instructed to immediately stop using the affected ventilator and retrieve the replacement kit provided free of charge. In addition, the letter states that if the product was further distributed, to contact their customers and notify them of the recall. Customers were asked to complete and return the enclosed Replacement form as replacements are completed. For questions contact Newport Medical Technical Support Department at 800-451-3111, extension 282, for U.S. customers; 714-427-5811, extension 500, for international customers.".

Recall details

Recall number
Z-2250-2012
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Aug 3, 2012
Posted by the FDA
Apr 14, 2014
Recalling firm
Newport Medical Instruments Inc
Quantity
72
Product code
CBK
FDA submissions
K090888, K111146
Distribution
Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.

Product description

Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system 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 HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Code information (models, lots, serial numbers)

Model Number: HT70 and HT70 Plus.  Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236, N12HT700514238 to N12HT700614280, N12HT700614282 to N12HT700614299, N12HT700614301 to N12HT700614309, N12HT720410266 to N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294 to N12HT720510300, N12HT720510302, N12HT720510322 to N12HT720510330, N12HT720510332 to N12HT720510344.

Other devices under the same FDA submission

15 devices cleared under K090888, K111146 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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