Z-1375-05

Newport HT50 All Purpose Ventilator

Name: Z-1375-05 Newport HT50 All Purpose Ventilator
Creator: Newport Medical Instruments Inc
Published: 2005-10-29
License: https://open.fda.gov/license/

Newport Medical Instruments, Inc. / initiated 2005-10-29 / Terminated

FDA source

Newport Medical Instruments Inc began a recall of Newport HT50 All Purpose Ventilator on 2005-10-29. The reason FDA records is "Lack of alarm prior to shutdown". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1375-05
Status: Terminated
Initiated: 2005-10-29
Posted: 2005-08-17
Terminated: 2012-08-02
Recalling firm: Newport Medical Instruments, Inc.
Product: Newport HT50 All Purpose Ventilator
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Lack of alarm prior to shutdown.
FDA 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 in commerce: 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, 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.
Product 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.

Product code CBK

K992133Class IINewport Ht50 Ventilator with Humidifier Ht50-H, Newport Ht50 Ventilator without Humidifier, Ht50-H1, Newport Ht50 VentilNewport Medical Instruments, Inc. / cleared 2000-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)