Hamilton Medical, Inc. recalls Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for…

Recall date

June 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1963-2015

FDA classification

Class II

Brand / firm

Hamilton Medical, Inc.

Sold / distributed

US Nationwide Distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.