Z-1570-2022Class II

The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding...

Name: Z-1570-2022 The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding...
Creator: Baxter Healthcare Corporation
Published: 2022-07-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-07-14 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source... on 2022-07-14. FDA classified it as Class II and gives the reason as "There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1570-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-14
Posted: 2022-08-24
Recalling firm: Baxter Healthcare Corporation
Product: The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter issued an URGENT DEVICE CORRECTION notice by mail on 07/14/2022. Baxter sent a follow-up notice dated 6/28/2023, stating Customers may return to using all 24 ports on their compounders when using newly manufactured EXACTAMIX 2400 Valve Sets (product code H938724, lot 60459942 and sequentially higher). Contact Baxter Technical Support M-F 8am-7pm ET at 800-678-2292 for help establishing/restoring a 24-port configuration for compounding, if not on drop-down menu. Lot numbers 60459941 and lower MUST use only 20 ports, omitting ports 1-4. For these sets: Baxter Technical Service added new compounder configurations for temporary use that omit the use of ports 1-4, and only use ports 5-24 for the ingredients on your compounder. For valve sets Lot numbers 60459941 and lower, a maximum of 20 ingredients can be pumped via the compounder. Observe the pumping process to monitor for leaks and unintended white or yellow discolored solution pumping through the valve set tubing into the final container. If unintended transfer of solutions from ports 1-4 are seen, abort the compounding process, discard the final container, replace the valve set, and report the incident to Baxter Product Surveillance. Depending on the ingredients on ports 1-4 and the respective volumes, customers may be able to add these ingredients as manual additions. Consider the type of ingredient to avoid precipitation based on the sequence of those additions. Continue to follow your institutional policy and procedures for compounding. The use of a 1.2-micron filter is a recommended best practice by ASPEN when administering all parenteral nutrition formulations.
Quantity in commerce: 448,960 units
Distribution: Worldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil, Colombia, Dominican Republic, Panama, Puerto Rico, Hong Kong, Taiwan, Korea, United Kingdom, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Kuwait, Netherlands, Oman, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.
Product codes and lots: Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1570-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1570-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)