FDAFDA · Food and drugs·Recall number Z-1001-2024
Baxter Exactamix Pro 1200, REF EXM12DY
Published February 28, 2024 · Recall initiated: December 22, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,
- Lot
- UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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