Baxter Healthcare Corporation: Automated Compounding Device Inlets Recalled for Particulate Matter

Agency Publication Date: September 19, 2024

Summary

Baxter Healthcare Corporation has recalled approximately 13,097,651 ExactaMix and ExactaMix Pro Automated Compounding Device Inlets due to reports of particulate matter found within the sterile fluid path tubing and packaging before use. These disposable inlets are used in pharmacies to prepare medications. The recall includes four different models—High Volume (Non-Vented and Vented), Micro-Volume, and Syringe Inlets—that were distributed worldwide.

Risk

The presence of particulate matter in the sterile fluid path can contaminate medications during the compounding process. If these particles are infused into a patient, it could lead to serious health complications such as inflammation, allergic reactions, or blockages in blood vessels.

What You Should Do

Identify if you have the affected Baxter EXACTAMIX Inlets by checking the Product Code (REF) and Lot Numbers on the packaging.
For EXACTAMIX Inlet, Non-Vented, High Volume (REF H938173), check for Lot Numbers 803806 and lower.
For EXACTAMIX Inlet, Vented, High Volume (REF H938174), check for Lot Numbers 803799 and lower.
For EXACTAMIX Inlet, Vented, Micro-Volume (REF H938175), check for Lot Numbers 803808 and lower.
For EXACTAMIX Inlet, Vented, Syringe Inlet (REF H938176), check for Lot Numbers 803807 and lower.
If your product matches the affected REF and Lot Numbers, stop using the device immediately and set the items aside to prevent accidental use.
Contact your healthcare provider or Baxter Healthcare Corporation directly for further instructions regarding the return or replacement of these products and to discuss potential refunds.
For additional questions, 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 notification and customer instructions

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

Affected Products

Product: Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet

Model / REF:

H938173

Z-3082-2024

UPC Codes:

00085412475783

Lot Numbers:

803806 and lower

Product: Baxter EXACTAMIX Inlet, Vented, High Volume Inlet

Model / REF:

H938174

Z-3083-2024

UPC Codes:

00085412475790

Lot Numbers:

803799 and lower

Product: Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet

Model / REF:

H938175

Z-3084-2024

UPC Codes:

00085412475806

Lot Numbers:

803808 and lower

Product: Baxter EXACTAMIX Inlet, Vented, Syringe Inlet

Model / REF:

H938176

Z-3085-2024

UPC Codes:

00085412475813

Lot Numbers:

803807 and lower

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95192

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 4 products (3,580,283 units; 1,548,782 units; 5,828,540 units; 2,140,046 units)

Distributed To: Nationwide

Agency Last Updated: October 22, 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

Identify if you have the affected Baxter EXACTAMIX Inlets by checking the Product Code (REF) and Lot Numbers on the packaging.

For EXACTAMIX Inlet, Non-Vented, High Volume (REF H938173), check for Lot Numbers 803806 and lower.

For EXACTAMIX Inlet, Vented, High Volume (REF H938174), check for Lot Numbers 803799 and lower.

For EXACTAMIX Inlet, Vented, Micro-Volume (REF H938175), check for Lot Numbers 803808 and lower.

For EXACTAMIX Inlet, Vented, Syringe Inlet (REF H938176), check for Lot Numbers 803807 and lower.

If your product matches the affected REF and Lot Numbers, stop using the device immediately and set the items aside to prevent accidental use.

Contact your healthcare provider or Baxter Healthcare Corporation directly for further instructions regarding the return or replacement of these products and to discuss potential refunds.

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

Affected Products

Product: Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet

Model / REF:

H938173

Z-3082-2024

UPC Codes:

00085412475783

Lot Numbers:

803806 and lower

Product: Baxter EXACTAMIX Inlet, Vented, High Volume Inlet

Model / REF:

H938174

Z-3083-2024

UPC Codes:

00085412475790

Lot Numbers:

803799 and lower

Product: Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet

Model / REF:

H938175

Z-3084-2024

UPC Codes:

00085412475806

Lot Numbers:

803808 and lower

Product: Baxter EXACTAMIX Inlet, Vented, Syringe Inlet

Model / REF:

H938176

Z-3085-2024

UPC Codes:

00085412475813

Lot Numbers:

803807 and lower

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95192

Status: Active

Manufacturer: Baxter Healthcare Corporation

Sold By: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 4 products (3,580,283 units; 1,548,782 units; 5,828,540 units; 2,140,046 units)

Distributed To: Nationwide

Agency Last Updated: October 22, 2024