Z-0377-04

Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in...

Name: Z-0377-04 Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in...
Creator: Baxter Healthcare Corp.
Published: 2003-12-16
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2003-12-16 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in preparation of parenteral solutions; Baxter Healthcare... on 2003-12-16. The reason FDA records is "The compounder may omit an ingredient during the compounding process". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0377-04
Status: Terminated
Initiated: 2003-12-16
Posted: 2004-01-29
Terminated: 2005-04-18
Recalling firm: Baxter Healthcare Corporation
Product: Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in preparation of parenteral solutions; Baxter Healthcare Corporation, Clintec Nutriiton Division, Deerfield, IL 60015 USA
Product code: LHI--
Reason for recall: The compounder may omit an ingredient during the compounding process.
FDA root cause: Other
Action: Baxter telephoned the accounts on 12/16/03, informing them of the potential for the Micromix BCR to omit an ingredient during the compounding process. The accounts were instructed to cease use of the Micromix BCR and return the units to Baxter via next day delivery.
Quantity in commerce: 6 units
Distribution: Wisconsin and Utah.
Product codes and lots: Serial numbers T2001/T20014, T20016/T20018, T20021, T20023/T20028

Product code LHI--

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)