Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for
FDA device recall Z-1964-2015 · posted 2015-07-02 · Terminated
Recall details
- Recalling firm
- Hamilton Medical, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- BZO
- Quantity affected
- 154 total, all part numbers
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2015-06-01
- Date posted
- 2015-07-02
- Date terminated
- 2015-08-12
- Location
- Reno, NV
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFANT FLOW SYSTEM (K945740) | Hamilton Medical, Inc. | 1995-03-23 |