—#31081

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

FDA product code: LHI--
Affected lot / code info: Serial numbers T2001/T20014, T20016/T20018, T20021, T20023/T20028

Why it was recalled

The compounder may omit an ingredient during the compounding process.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Wisconsin and Utah.

Timeline

Recall initiated: 2003-12-16
Posted by FDA: 2004-01-29
Terminated: 2005-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #31081. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.