medical Class I Updated 2024-02-28

Baxter Healthcare Corporation recalls Baxter Exactamix Pro 1200, REF EXM12DY

Recalled Product

Baxter Exactamix Pro 1200, REF EXM12DY


Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI
Lot/Code Info: UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005
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