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U.S. Department of Health and Human Services

Class 2 Device Recall Infant Flowsensor

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  Class 2 Device Recall Infant Flowsensor see related information
Date Initiated by Firm June 01, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on August 12, 2015
Recall Number Z-1964-2015
Recall Event ID 71434
510(K)Number K945740  
Product Classification Set, tubing and support, ventilator (w harness) - Product Code BZO
Product Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators.

Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
Code Information PN 155500, all lot codes.
Recalling Firm/
Manufacturer		 Hamilton Medical, Inc.
4990 Energy Way
Reno NV 89502-4123
For Additional Information Contact Daniel Bellanger
775-858-3200 Ext. 210
Manufacturer Reason
for Recall		 An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
FDA Determined
Cause 2		 Device Design
Action Hamilton Medical Inc sent a Medical Device Safety Notices letter dated May 8, 2015 by traceable method to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Technical Support Manager at 800-426-6331, Ext 215.
Quantity in Commerce 154 total, all part numbers
Distribution US Nationwide Distribution.
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 = BZO and Original Applicant = HAMILTON MEDICAL, INC.
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