Z-1371-2008

Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients...

Name: Z-1371-2008 Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients...
Creator: Baxa Corporation
Published: 2008-02-11
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2008-02-11 / Terminated / root cause: software

FDA source

Baxa Corporation began a recall of Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified... on 2008-02-11. The reason FDA records is "Flush solution from TPN compounder may be added to patient's TPN bag". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1371-2008
Status: Terminated
Initiated: 2008-02-11
Posted: 2008-08-19
Terminated: 2012-03-16
Recalling firm: Baxter Corporation Englewood
Product: Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: Flush solution from TPN compounder may be added to patient's TPN bag.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified by letter (Exacta-Mix Compounder Software Safety Alert) on 02/11/2008 advising them of the necessity to install a waste bag prior to a machine flush.
Quantity in commerce: 221 units
Distribution: Nationwide, including military facilities in CA, FL, HI, MS, NC, TX, VA and VA facilities in NY, OR, SC, UT. Foreign distribution to Australia, Canada, China and New Zealand.
Product codes and lots: Model 071B-RS232, all serial numbers

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)