FDA Enforcement
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.
Recall: Z-1963-2015
·
Reported July 8, 2015
Enforcement
- Recall Number
- Z-1963-2015
- Event ID
- 71434
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hamilton Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 8, 2015
- Initiation Date
- June 1, 2015
- Classification Date
- July 2, 2015
- Termination Date
- August 12, 2015
- Address
- 4990 Energy Way, Reno, NV, 89502-4123, United States
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
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.
Code Info
PN 260177, all lot codes.
Distribution
US Nationwide Distribution.
Quantity
154 total - all part numbers