Recall Z-1375-05 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
Newport HT50 All Purpose Ventilator
| Date | Aug 17, 2005 (initiated Oct 29, 2005) |
| Status | Terminated |
| Reason | Lack of alarm prior to shutdown. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Liechtenstein |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992133 | NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL Newport Medical Instruments, Inc., Aug 4, 2000 |