Date Initiated by Firm | June 01, 2015 |
Date Posted | July 02, 2015 |
Recall Status1 |
Terminated 3 on August 12, 2015 |
Recall Number | Z-1963-2015 |
Recall Event ID |
71434 |
510(K)Number | K945740 |
Product Classification |
Set, tubing and support, ventilator (w harness) - Product Code BZO
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Product | Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. 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 260177, all lot codes. |
Recalling Firm/ Manufacturer |
Hamilton Medical, Inc. 4990 Energy Way Reno NV 89502-4123
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = BZO
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