Z-1001-2024 Class I Ongoing
FDA device recall Z-1001-2024 was initiated by Baxter Healthcare Corporation on December 22, 2023 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 8 devices.
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
- 8 devices
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.
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 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005