Newport HT50 All Purpose Ventilator
FDA device recall Z-1375-05 · posted 2005-08-17 · Terminated
Recall details
- Recalling firm
- Newport Medical Instruments Inc
- Reason for recall
- Lack of alarm prior to shutdown.
- Action taken
- Notice of Field Correction was sent to consignees dated 10/29/2004. A second notice was sent 12/20/04 announcing that materials for conducting an upgrade were being sent which included a manual insert and brochure regarding the battery. Also request was made to return products as they are available. Notice was sent 12/20/04 that field correction kits were available for order. Recall is ongoing.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 3654
- Distribution
- Nationwide and Argentina, Australia, Bangledesh, Belgium, Bolivia, Brazil, Bulgria, Canada, Chile, Hong Kong, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, German
- Date initiated
- 2005-10-29
- Date posted
- 2005-08-17
- Date terminated
- 2012-08-02
- Location
- Costa Mesa, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |