B. Braun Medical, Inc.: Anesthesia Extension Sets Recalled for Potential Product Leakage

Agency Publication Date: September 13, 2024

Summary

B. Braun Medical, Inc. is recalling approximately 19,050 units of the AET36 Anesthesia Extension Set (Model 472036) due to a defect that can cause the device to leak. Excess solvent used during the assembly process can migrate into the Spin Lock Connector, causing it to fail and allow fluids to escape during medical procedures. While this is a voluntary firm-initiated recall, patients and healthcare providers should be aware that a leak could lead to a loss of critical fluids or medication.

Risk

A leak at the Spin Lock Connector can interrupt the delivery of anesthesia or other fluids to a patient, potentially leading to under-dosing or exposure of the clinical environment to medical fluids. There are no reported injuries at this time, but the defect poses a risk of treatment failure during surgical or anesthesia procedures.

What You Should Do

Identify if you have the affected AET36 Anesthesia Extension Set by checking the packaging for Model/Catalog Number 472036 and UDI-DI 04046964184659.
Check your inventory for the following specific affected lot numbers: 0061898815, 0061905158, 00VL872690, 00VL882317, and 00VL882319.
If you possess any of the affected lots, immediately stop using the product and quarantine the devices to ensure they are not used in clinical settings.
Contact your healthcare provider or B. Braun Medical, Inc. at their Allentown, PA headquarters (901 Marcon Blvd) for further instructions on returning the product and obtaining a potential refund or replacement.
For additional information or questions regarding this recall, 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

Product return and manufacturer consultation

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

Affected Products

Product: AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock

Model / REF:

472036

UPC Codes:

04046964184659

Lot Numbers:

0061898815

0061905158

00VL872690

00VL882317

00VL882319

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95153

Status: Active

Manufacturer: B. Braun Medical, Inc.

Sold By: B. Braun Medical, Inc. distribution channels

Manufactured In: United States

Units Affected: 19050 units

Distributed To: Nationwide

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

Risk

What You Should Do

Identify if you have the affected AET36 Anesthesia Extension Set by checking the packaging for Model/Catalog Number 472036 and UDI-DI 04046964184659.

Check your inventory for the following specific affected lot numbers: 0061898815, 0061905158, 00VL872690, 00VL882317, and 00VL882319.

If you possess any of the affected lots, immediately stop using the product and quarantine the devices to ensure they are not used in clinical settings.

Contact your healthcare provider or B. Braun Medical, Inc. at their Allentown, PA headquarters (901 Marcon Blvd) for further instructions on returning the product and obtaining a potential refund or replacement.

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