Baxter Healthcare Corporation: Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

Agency Publication Date: May 22, 2018

Affected Products

Product: Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

UDI: 00085412475783 Lot Numbers: 802277, 802278, 802383, 802384, 802385

Lot Numbers:

Numbers

Product: Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

UDI: 00085412475790 Lot Numbers: 802279, 802280, 802281

Lot Numbers:

Numbers

Product: Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

UDI: 00085412475806 Lot Numbers: 802282, 802283

Lot Numbers:

Numbers

Product: Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

UDI: 00085412475813 Lot numbers: 802284, 802285, 802286

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79975

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 4 products (98700 units; 59475 units; 75350 units; 112975 units)

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.

Affected Products

UDI: 00085412475783 Lot Numbers: 802277, 802278, 802383, 802384, 802385

Lot Numbers:

Numbers

UDI: 00085412475790 Lot Numbers: 802279, 802280, 802281

Lot Numbers:

Numbers

UDI: 00085412475806 Lot Numbers: 802282, 802283

Lot Numbers:

Numbers

UDI: 00085412475813 Lot numbers: 802284, 802285, 802286

Lot Numbers:

numbers