Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventil
FDA device recall Z-2295-2011 · posted 2011-05-26 · Terminated
Recall details
- Recalling firm
- Newport Medical Instruments Inc
- Reason for recall
- The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.
- Action taken
- Newport Medical Instruments, Inc. sent an FIELD CORRECTION letter dated January 13, 2009, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. The Newport HT50 ventilators that were shipped in December 2008, were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. The customer were also requested to complete the attached customer REWORK INSTRUCTIONS form and fax it to (714) 427-0489. If you have any further questions, please call (714) 427-5811 x 344
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Distribution
- Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey.
- Date initiated
- 2009-01-13
- Date posted
- 2011-05-26
- Date terminated
- 2011-06-01
- Location
- Costa Mesa, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL (K992133) | Newport Medical Instruments, Inc. | 2000-08-04 |