PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 8, 2015 Initiated: June 1, 2015 #Z-1963-2015

Product Description

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.

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.

Details

Recalling Firm
Hamilton Medical, Inc.
Units Affected
154 total - all part numbers
Distribution
US Nationwide Distribution.
Location
Reno, NV

Frequently Asked Questions

What product was recalled?
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.. Recalled by Hamilton Medical, Inc.. Units affected: 154 total - all part numbers.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1963-2015.