Baxter Exactamix Pro 1200, REF EXM12DY
FDA Recall #Z-1001-2024 — Class I — December 22, 2023
Product Description
Baxter Exactamix Pro 1200, REF EXM12DY
Reason for Recall
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.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product 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,
Code Information
UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated