Z-1002-2024 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
February 28, 2024
Initiation Date
December 22, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
67 devices

Product Description

Baxter Exactamix Pro 2400, REF EXM24DY

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.

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,

Code Information

UDI/DI 05413765588136, Serial Numbers: PLD0019873, PLD2311023, PLD2325014, PLD2339015, PLD0019879, PLD2311029, PLD2325016, PLD2339016, PLD2245007, PLD2311031, PLD2325017, PLD2339017, PLD2303007, PLD2311034, PLD2325018, PLD2339018, PLD2303008, PLD2311036, PLD2325019, PLD2339019, PLD2310013, PLD2325001, PLD2328033, PLD2339020, PLD2310018, PLD2325002, PLD2328034, PLD2339021, PLD2310024, PLD2325003, PLD2328035, PLD2339022, PLD2310025, PLD2325004, PLD2328036, PLD2339023, PLD2310026, PLD2325005, PLD2328037, PLD2339024, PLD2310030, PLD2325006, PLD2328038, PLD2339025, PLD2311001, PLD2325007, PLD2328039, PLD2339026, PLD2311012, PLD2325009, PLD2328043, PLD2339027, PLD2311013, PLD2325010, PLD2339004, PLD2339028, PLD2311014, PLD2325011, PLD2339012, PLD2339029, PLD2311016, PLD2325012, PLD2339013, PLD2342001, PLD2311022, PLD2325013, PLD2339014