Class 2 Device Recall Micromix BCR Compounder

• Date Initiated by Firm: December 16, 2003
• Date Posted: January 29, 2004
• Recall Status: Terminated on April 18, 2005
• Recall Number: Z-0377-04
• Recall Event ID: 28038
• Product Classification: unknown device name - Product Code LHI--
• 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
• Code Information: Serial numbers T2001/T20014, T20016/T20018, T20021, T20023/T20028
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: The compounder may omit an ingredient during the compounding process.
• FDA Determined 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.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.