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U.S. Department of Health and Human Services

Class 2 Device Recall Micromix BCR Compounder

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  Class 2 Device Recall Micromix BCR Compounder see related information
Date Initiated by Firm December 16, 2003
Date Posted January 29, 2004
Recall Status1 Terminated 3 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 2		 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.
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