# K002705: Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400

- Pathway: 510(k) (Traditional)
- Applicant: Baxa Corp.
- Decided: Mar 28, 2001 after 210 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 15 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 5 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022523: Rapid-Fill Tubeset, Model 90005 (2002), 1 descendant of its own
- K192770: S dispensing line (2020), 0 descendants of its own
- K151423: APEX Compounding System Transfer Set (2016), 0 descendants of its own
- K132011: Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer Set (2014), 0 descendants of its own
- K041222: Pinnacle TPN Management System Transfer Set (2004), 0 descendants of its own

## Recalls of this device
- Apr 22, 2026 · Class II · Z-2262-2026: Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingr
- Aug 20, 2024 · Class I · Z-3085-2024: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938
- Aug 20, 2024 · Class I · Z-3083-2024: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938
- Aug 20, 2024 · Class I · Z-3082-2024: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938
- Aug 20, 2024 · Class I · Z-3084-2024: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938
- Dec 22, 2023 · Class I · Z-1002-2024: 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
- Dec 22, 2023 · Class I · Z-1001-2024: 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
- Jul 14, 2022 · Class II · Z-1570-2022: There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
- Apr 25, 2018 · Class II · Z-1908-2018: Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If t
- Apr 25, 2018 · Class II · Z-1910-2018: Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If t
- Apr 25, 2018 · Class II · Z-1911-2018: Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If t
- Apr 25, 2018 · Class II · Z-1909-2018: Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If t
- Jun 4, 2013 · Class II · Z-1752-2013: Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the devi
- Feb 10, 2010 · Not classified · Z-1197-2010: Molding defect in the valve body causes leaking.
- Nov 7, 2003 · Not classified · Z-0210-04: If device stops due to an alarm or operater pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber..

Source page: https://510kreport.com/device/K002705
Methodology: https://510kreport.com/methodology