Newport HT50 All Purpose Ventilator

Date posted by the FDA

Aug. 17, 2005

Status

Terminated

Filed by

Newport Medical Instruments Inc

Product

Newport HT50 All Purpose Ventilator

Reason

Lack of alarm prior to shutdown.

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.

Quantity

3654

Codes and lots

All serial numbers. Products are identified by serial numbers on back of ventilators. Manufacturer states serial numbers of ventilators involved in field correction may be obtained through shipping records.

Recall started

Oct. 29, 2005

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-1375-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1375-05. The agency record governs; check it and the company before acting.