RecallDepth

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.

Company
Hamilton Medical Inc
Recall Initiated
June 1, 2015
Posted
July 2, 2015
Terminated
August 12, 2015
Recall Number
Z-1963-2015
Quantity
154 total - all part numbers
Firm Location
Reno, NV

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.

Distribution

US Nationwide Distribution.

Lot / Code Info

PN 260177, all lot codes.

Root Cause

Device Design

Action Taken

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.

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