Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
Hamilton Medical is recalling Infant Flow Sensors because they may provide inaccurate flow measurements, causing ventilators to decrease ventilation in specific modes.
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 high-risk medical device where a defect could lead to decreased ventilation for patients, representing a risk of harm even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Hamilton Medical, Inc. is recalling the Hamilton Medical Infant Flow Sensor, single use (Part number 155500). This device is an accessory used with Hamilton Medical Ventilators to measure patient air flow and pressures. The recall involves 154 units distributed nationwide in the United States.
The recall is due to a defect where the sensor may provide inaccurate flow measurements when used with a ventilation mode with adaptive volume control (APVcmv/CMV+). If this occurs, the ventilator may adjust the ventilation based on the inaccurate data, resulting in a decrease in the amount of ventilation delivered to the patient.
Healthcare providers and facilities that have purchased or received these devices should stop using them and contact Hamilton Medical for further instructions. The recall covers all lot codes for Part number 155500.
The recalled product
- Product
- 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 V
- 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 155500
- 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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