Terminated

Newport HT50 All Purpose Ventilator

FDA Recall Z-1375-05 · Posted 2005-08-17

Recalling FirmNewport Medical Instruments Inc

Recall StatusTerminated

Product CodeCBK

Date Initiated2005-10-29

Date Terminated2012-08-02

Product Quantity3654

Reason for Recall

Lack of alarm prior to shutdown.

Firm 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.

Root Cause

Other

Distribution Pattern

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, Lithuania, Malaysia, Mexico, Netherlands, New Caldonia, Paraguay, Philipines, Poland, Portugal, Quatar, Republic of South Africa, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen Republic.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992133NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTILNewport Medical Instruments, Inc. · 2000-08-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.