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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 inaccurate measurements may lead to decreased ventilation delivery, representing a risk of harm without reported injuries.
Plain-English summary
Hamilton Medical, Inc. is recalling the Hamilton Medical Infant Flow Sensor, single use, Part number 260179. This device is an accessory used to measure patient air flow and pressures within Hamilton Medical Ventilators. A total of 154 units were distributed nationwide in the United States.
The recall was initiated because an issue was discovered where the ventilator may adjust ventilation based on inaccurate flow measurements when using a ventilation mode with adaptive volume control (APVcmv/CMV+). This inaccuracy may result in the ventilator decreasing the amount of ventilation delivered to the patient.
Healthcare facilities and users should stop using the affected infant flow sensors and contact Hamilton Medical for further instructions or replacement.
The recalled product
- Product
- Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. 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…
- 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 260179
- 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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