Recall Z-1964-2015 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
Hamilton Medical, Inc.
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. 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.
| Date | Jul 2, 2015 (initiated Jun 1, 2015) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 154 total, all part numbers |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945740 | INFANT FLOW SYSTEM Hamilton Medical, Inc., Mar 23, 1995 |