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Recall Observatory FDA recall evidence

Device product

Baxter Exactamix Pro 1200, REF EXM12DY

Z-1001-2024

December 22, 2023

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 93700
Status
Ongoing
Classification
Class I
Quantity
8 devices
Official record key
device-enforcement:Z-1001-2024

Official wording

Reason: 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.

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

Distribution pattern: US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    error was identified in software