Baxter Healthcare Corporation: Baxter Exactamix Pro 2400, REF EXM24DY

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.

Details from the source

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: US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI, Quantity: 67 devices Lot/code info: 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

UPC codes

05413765588136

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.