Recall Z-2250-2012 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
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, pedi
| Date | Apr 14, 2014 (initiated Aug 3, 2012) |
| Status | Terminated |
| Reason | May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board. |
| Root cause | Nonconforming Material/Component |
| Action | 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 c |
| Quantity | 72 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa. |
| FDA record | Open on fda.gov |