Z-1001-2024Class I

Baxter Exactamix Pro 1200, REF EXM12DY

Name: Z-1001-2024 Baxter Exactamix Pro 1200, REF EXM12DY
Creator: Baxter Healthcare Corporation
Published: 2023-12-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-12-22 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Baxter Exactamix Pro 1200, REF EXM12DY on 2023-12-22. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1001-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-22
Posted: 2024-02-16
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Exactamix Pro 1200, REF EXM12DY
Product code: LHI Set, I.V. Fluid Transfer
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.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter issued an Urgent Medical Device Correction notice to its consignees on 12/22/2023 via USPS First Class mail. The notice explained the issue with the device, potential risks, and requested the following actions be taken for the safe operation until a software upgrade is released: "1. Operators may continue to use the ExactaMix Pro compounders, but when the system prompts the operator that ingredients are depleted, operators should choose to Swap Container or Use a Different Container and not utilize the Use Some Overfill feature until further notice by Baxter. For more information on alternatives to using overfill, refer to the information on Replacing a Source Container on pages 82-83 in the ExactaMix Pro 2400 Operator Manual and pages 83-84 in the ExactaMix Pro 1200 Operator Manual. 2. If the Use Some Overfill feature is inadvertently used, operators must ensure that: o The Use Some Overfill feature is used only ONCE when an ingredient is depleted. o When prompted to enter the volume of overfill to use, enter LESS THAN the volume left to run stated in the Swap Container window. o On the MixCheck report, verify that all ingredient deliveries that used overfill volume delivered the expected ingredient volume and that the final total volume for the bag aligns with the expected volume. o If you observe redundant ingredient delivery using the overfill volume per the MixCheck report, discard the bag. 3. Always review the final MixCheck report as described in the ExactaMix Pro Operator Manual. Please review the information on this feature on pages 167-171 in the ExactaMix Pro 2400 Operator Manual and pages 164-168 in the ExactaMix Pro 1200 Operator Manual. 4. A Baxter representative will contact your facility when the software upgrade becomes available. Please note you will be receiving this upgrade from Baxter at no charge." If the affected product was distributed to other facilities or departments within your institution, please forward a copy of
Quantity in commerce: 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,
Product codes and lots: UDI/DI 05413765588150, Serial Numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, LD2339005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1001-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1001-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1002-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16

Product code LHI

K002705Class IIExacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. / cleared 2001-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)