Belmont 3.0 Liter Disposable Sets for Rapid Infuser Recalled for Fluid Leaks

Agency Publication Date: April 25, 2025

Summary

Belmont Instrument LLC is recalling 603 cases (totaling 2,412 sets) of its 3.0 Liter Disposable Sets used with Rapid Infuser machines. The female quick connector on the patient line component may have a crack, which can cause fluids to leak while the machine is being prepared for use. No injuries or incidents have been reported, but the manufacturer is voluntarily recalling these specific lots to prevent potential treatment delays.

Risk

A cracked connector causes fluid to leak during the priming of the infusion device, which could result in a delay of critical fluid or blood delivery to a patient in an emergency medical situation.

What You Should Do

This recall involves 3.0 Liter Disposable Sets (Model Number 903-00032) used with Rapid Infusers, specifically lot numbers 20240911, 20241004, 20241011, and 20241105.
Check the model and lot numbers printed on the individual pouches or the shipping case to see if your supplies are affected. The sets include both a Large Volume Reservoir and a Heat Exchanger/Patient Line set.
Stop using the recalled device immediately to prevent leaks and potential treatment delays.
Contact Belmont Instrument LLC or your medical distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
For additional questions or to report issues, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: 3.0 Liter Disposable Set (4 sets/case)

Model / REF:

903-00032

Lot Numbers:

20240911

20241004

20241011

20241105

UDI:

00896128002534

Consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line sets (P/N 403-00382).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96625

Status: Active

Manufacturer: Belmont Instrument LLC

Sold By: Medical distributors; Direct to hospitals

Manufactured In: United States

Units Affected: 603 cases (2,412 sets)

Distributed To: Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves 3.0 Liter Disposable Sets (Model Number 903-00032) used with Rapid Infusers, specifically lot numbers 20240911, 20241004, 20241011, and 20241105.

Check the model and lot numbers printed on the individual pouches or the shipping case to see if your supplies are affected. The sets include both a Large Volume Reservoir and a Heat Exchanger/Patient Line set.

Stop using the recalled device immediately to prevent leaks and potential treatment delays.

Contact Belmont Instrument LLC or your medical distributor to arrange for the return, replacement, or correction of any affected units in your inventory.

For additional questions or to report issues, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).