Fresenius Kabi USA, LLC: LVP Primary Administration Sets Recalled Due to Medication Overdose Risk

Agency Publication Date: September 4, 2024

Summary

Fresenius Kabi USA, LLC has recalled 180 cases (approximately 4,500 pieces) of LVP Primary Administration Sets, which are used for intravenous infusions. A defect in these sets can cause medication to flow at an uncontrolled rate, which may result in a patient receiving a much higher dose than prescribed. Consumers and healthcare providers should contact the manufacturer or their healthcare provider immediately for guidance on managing affected products.

Risk

The defect allows for an uncontrolled medication flow condition. This mechanism of failure can lead to a dangerous medication overdose, posing a critical health risk to the patient receiving the infusion.

What You Should Do

Identify the affected product by looking for the 'LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site' labeled as Product Code SET-0013-25.
Check your supplies specifically for Lot number 3010538 and UDI-DI 00811505030054.
If you identify an affected administration set, contact your healthcare provider or the manufacturer for instructions on how to handle or return the product.
Patients who believe they have been affected by an uncontrolled flow from this device should seek medical attention from their healthcare provider immediately.
Contact Fresenius Kabi USA, LLC or the distributor at 50 High St Ste 50, North Andover, MA 01845 for further information regarding potential replacements or refunds.
For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit their website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer instructions for device defect

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25)

Model / REF:

SET-0013-25

UDI-DI: 00811505030054

Lot Numbers:

3010538

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95113

Status: Active

Manufacturer: Fresenius Kabi USA, LLC

Sold By: medical distributors

Manufactured In: United States

Units Affected: 180 cases/4,500 pieces

Distributed To: Colorado, Idaho, New Jersey, Utah

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

Identify the affected product by looking for the 'LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site' labeled as Product Code SET-0013-25.

Check your supplies specifically for Lot number 3010538 and UDI-DI 00811505030054.

If you identify an affected administration set, contact your healthcare provider or the manufacturer for instructions on how to handle or return the product.

Patients who believe they have been affected by an uncontrolled flow from this device should seek medical attention from their healthcare provider immediately.

Contact Fresenius Kabi USA, LLC or the distributor at 50 High St Ste 50, North Andover, MA 01845 for further information regarding potential replacements or refunds.

For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit their website at www.fda.gov/medical-devices/medical-device-recalls.