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U.S. Department of Health and Human Services

Class 2 Device Recall Newport HT50 Ventilator

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 Class 2 Recall
Newport HT50 Ventilator
see related information
Date Posted May 26, 2011
Recall Status1 Terminated on June 01, 2011
Recall Number Z-2295-2011
Recall Event ID 58612
Premarket Notification
510(K) Number
K992133 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Newport HT50® Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.
Code Information Device Listing Number: D0004206 Serial Numbers: N08HT501212491 through N08HT501212523
Recalling Firm/
Manufacturer
Newport Medical Instruments Inc
1620 Sunflower Ave
Costa Mesa, California 92626-1513
Consumer Instructions Contact your health professional
Manufacturer Reason
for Recall
The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Newport Medical Instruments, Inc. sent an FIELD CORRECTION letter dated January 13, 2009, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. The Newport HT50 ventilators that were shipped in December 2008, were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. The customer were also requested to complete the attached customer REWORK INSTRUCTIONS form and fax it to (714) 427-0489. If you have any further questions, please call (714) 427-5811 x 344.
Distribution Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.
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