Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sen...

FDA Device Recall #Z-1963-2015 — Class II — June 1, 2015

Recall Summary

Recall Number Z-1963-2015
Classification Class II — Moderate risk
Date Initiated June 1, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hamilton Medical, Inc.
Location Reno, NV
Product Type Devices
Quantity 154 total - all part numbers

Product Description

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 Ventilators.

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.

Distribution Pattern

US Nationwide Distribution.

Lot / Code Information

PN 260177, all lot codes.

Other Recalls from Hamilton Medical, Inc.

Recall # Classification Product Date
Z-2525-2023 Class I Hamilton-C1, REF: 161001, Portable Intensive Ca... Jul 26, 2023
Z-2528-2023 Class I Hamilton-MR1, REF: 161010, Intensive Care Venti... Jul 26, 2023
Z-2529-2023 Class I Hamilton C1/T1/MR1, REF: MSP161502/12, Control ... Jul 26, 2023
Z-2526-2023 Class I Hamilton-T1, REF: 161006, Intensive Care and Tr... Jul 26, 2023
Z-2530-2023 Class I Hamilton-T1, REF: MSP161339/02, ESM Shielding S... Jul 26, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.