FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 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
- Recall number
- Z-0377-04
- Recalling firm
- Baxter Healthcare Corp.
- 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
- Status
- Terminated
- Initiated
- 2003-12-16
- Posted
- 2004-01-29
- Terminated
- 2005-04-18
- Reason
- The compounder may omit an ingredient during the compounding process.
- 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
- 6 units
- Distribution
- Wisconsin and Utah.
- Lot, serial or model codes
- Serial numbers T2001/T20014, T20016/T20018, T20021, T20023/T20028
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LHI--
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28