Z-0210-04

Exacta-Mix 2400 pharmacy compounding system

Name: Z-0210-04 Exacta-Mix 2400 pharmacy compounding system
Creator: Baxa Corporation
Published: 2003-11-07
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2003-11-07 / Terminated

FDA source

Baxa Corporation began a recall of Exacta-Mix 2400 pharmacy compounding system on 2003-11-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0210-04
Status: Terminated
Initiated: 2003-11-07
Posted: 2004-07-20
Terminated: 2004-02-24
Recalling firm: Baxter Corporation Englewood
Product: Exacta-Mix 2400 pharmacy compounding system.
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: 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..
FDA root cause: Other
Action: All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.
Quantity in commerce: 231 systems
Distribution: Nationwide. Foreign distribution to UK. No government or military consignees.
Product codes and lots: Catalog Number EM2400, all serial numbers.

Product code NEP

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)