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U.S. Department of Health and Human Services

Class 2 Device Recall ExactaMix 2400(EM2400) Compounder Operating Ststem

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  Class 2 Device Recall ExactaMix 2400(EM2400) Compounder Operating Ststem see related information
Date Initiated by Firm March 23, 2009
Date Posted April 09, 2012
Recall Status1 Terminated 3 on April 10, 2012
Recall Number Z-1389-2012
Recall Event ID 52024
Product Classification System/device, pharmacy compounding - Product Code NEP
Product Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities.

Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients
Code Information 2 model numbers 2400 D and 2400 M.
Recalling Firm/
Manufacturer		 Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112
For Additional Information Contact
303-690-4204
Manufacturer Reason
for Recall		 Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.
FDA Determined
Cause 2		 Software design
Action Baxa sent a Safety Alert letter dated March 23, 2009 to all affected consignees. The letter identified the affected product, problem and recommended actions with specific instructions related to the issue. Additionally, the firm will be providing a warning label for the affected product as soon as possible and is currently working on a product upgrade to correct the issue. For assistance contact Baxa Technical Support at 800-678-2292. The firm is also providing a 24 hour a day, 7 days a week Technical Support for the affected product.
Quantity in Commerce 1322 units
Distribution Worldwide Distribution - USA Nationwide including Canada.
Total Product Life Cycle TPLC Device Report
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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