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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 29, 2005
Date Posted August 17, 2005
Recall Status1 Terminated 3 on August 02, 2012
Recall Number Z-1375-05
Recall Event ID 31282
510(K)Number k992133  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Newport HT50 All Purpose Ventilator
Code Information 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.
Recalling Firm/
Manufacturer		 Newport Medical Instruments Inc
1620 Sunflower Ave.
Costa Mesa CA 92626
For Additional Information Contact Richard L. Waters
949-642-3910
Manufacturer Reason
for Recall		 Lack of alarm prior to shutdown.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.
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