Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent posi
FDA device recall Z-2406-2011 · posted 2011-06-02 · Terminated
Recall details
- Recalling firm
- Newport Medical Instruments Inc
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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, Singapo
- Date initiated
- 2010-09-20
- Date posted
- 2011-06-02
- Date terminated
- 2011-06-03
- Location
- Costa Mesa, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWPORT HT70 FAMILY OF VENTILATORS (K090888) | Newport Medical Instruments, Inc. | 2009-11-18 |