Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for life support (ventilation) where a defect could lead to decreased ventilation delivery. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hamilton Medical, Inc. is recalling 154 units of the Hamilton Medical Infant Flow Sensor, single use (Part number 260177). This device is an accessory used to measure patient air flow and pressures within Hamilton Medical Ventilators. The recall covers all lot codes and the product was distributed nationwide in the United States.
The recall is due to a defect where the ventilator may adjust ventilation based on inaccurate flow measurements when using adaptive volume control modes (APVcmv/CMV+). This inaccuracy may result in the ventilator decreasing the amount of ventilation delivered to the patient.
Healthcare facilities and users of these devices should stop using the affected Infant Flow Sensors and contact Hamilton Medical for instructions on replacement or return.
The recalled product
- Product
- 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 Ve
- Manufacturer
- Hamilton Medical, Inc.
- Affected units
- 154
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- PN 260177
- all lot codes.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Hamilton Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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