Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400

• • Ongoing Z-2262-2026 FDA Class II ·initiated 22 Apr 2026 ·on shared 510(k) K002705

  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 ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.

• 4 recalls, same reason

  • Ongoing Z-3084-2024 FDA Class I ·initiated 20 Aug 2024
  • Ongoing Z-3082-2024 FDA Class I ·initiated 20 Aug 2024
  • Ongoing Z-3083-2024 FDA Class I ·initiated 20 Aug 2024
  • Ongoing Z-3085-2024 FDA Class I ·initiated 20 Aug 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, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

• 2 recalls, same reason

  • Ongoing Z-1002-2024 FDA Class I ·initiated 22 Dec 2023
  • Ongoing Z-1001-2024 FDA Class I ·initiated 22 Dec 2023

  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.

• • Ongoing Z-1570-2022 FDA Class II ·initiated 14 Jul 2022

  There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

• 4 recalls, same reason

  • Terminated Z-1908-2018 FDA Class II ·initiated 25 Apr 2018
  • Terminated Z-1911-2018 FDA Class II ·initiated 25 Apr 2018
  • Terminated Z-1910-2018 FDA Class II ·initiated 25 Apr 2018
  • Terminated Z-1909-2018 FDA Class II ·initiated 25 Apr 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 the product is used beyond the expiration date,

• • Terminated Z-1752-2013 FDA Class II ·initiated 4 Jun 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 device to midnight December 31, 2010.

• • Terminated Z-1197-2010 FDA Unclassified (pre-2012) ·initiated 10 Feb 2010

  Molding defect in the valve body causes leaking.

• • Terminated Z-0210-04 FDA Unclassified (pre-2012) ·initiated 7 Nov 2003 ·on shared 510(k) K002705

  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..

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K002705 ↗

FDA Product Code

LHI

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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