Recall Z-2406-2011 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
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
| Date | Jun 2, 2011 (initiated Sep 20, 2010) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090888 | NEWPORT HT70 FAMILY OF VENTILATORS Newport Medical Instruments, Inc., Nov 18, 2009 |