FDAClass IFebruary 28, 2024

Baxter Exactamix Pro 1200 recall: Software Issue

Baxter Exactamix Pro 1200, REF EXM12DY

Why was Baxter Exactamix Pro 1200 recalled?

An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005

Product
Baxter Exactamix Pro 1200, REF EXM12DY
Recalling firm
Baxter Healthcare Corporation
Quantity
8 devices
Distribution
US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,
Recall date
February 28, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls