BD SWITZERLAND SARL: Alaris Pump Infusion Sets Recalled for Drip Chamber Detachment

Agency Publication Date: May 31, 2024

Summary

BD Switzerland SARL is recalling approximately 11,300 Alaris Pump Infusion Sets (Low Sorbing Tubing) due to a defect where the drip chamber can become detached from the tubing. This tubing is used to deliver critical fluids, medications, and blood products to patients. If the chamber detaches, it can cause significant delays in treatment or expose the patient to harsh medications that were intended to be contained within the sterile tubing system. Consumers should identify affected units by checking the catalog and lot numbers on the packaging.

Risk

A detached drip chamber can cause a leak or a break in the infusion line, potentially leading to an interruption in life-sustaining therapy or exposing users and patients to hazardous medicinal infusates.

What You Should Do

Locate the product packaging for the Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) with Back Check Valve and 2 SmartSite Y Sites.
Check the product label for Catalog Number 10013072 and Lot Number 22115368 with UDI-DI code 07613203021210.
Immediately stop using any infusion sets identified as part of the affected lot (Lot Number 22115368).
Contact your healthcare provider or the manufacturer, BD Switzerland SARL, for specific instructions on how to return the product and to discuss potential replacements or refunds.
Healthcare professionals should verify their inventory and quarantine any remaining units from the affected lot to prevent further use.
For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer and Healthcare Coordination

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

Affected Products

Product: Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites

Model / REF:

REF 10013072

Catalog Number: 10013072

UDI-DI code: 07613203021210

Lot Numbers:

22115368

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94479

Status: Active

Manufacturer: BD SWITZERLAND SARL

Sold By: Hospital and clinical supply channels

Manufactured In: Switzerland

Units Affected: 11.300 sets

Distributed To: Arkansas, California, Colorado, Illinois, Kansas, Massachusetts, Maine, New Jersey, New York, Pennsylvania, South Dakota, Washington, Wisconsin

Agency Last Updated: December 19, 2024

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

Locate the product packaging for the Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) with Back Check Valve and 2 SmartSite Y Sites.

Check the product label for Catalog Number 10013072 and Lot Number 22115368 with UDI-DI code 07613203021210.

Immediately stop using any infusion sets identified as part of the affected lot (Lot Number 22115368).

Contact your healthcare provider or the manufacturer, BD Switzerland SARL, for specific instructions on how to return the product and to discuss potential replacements or refunds.

Healthcare professionals should verify their inventory and quarantine any remaining units from the affected lot to prevent further use.

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