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U.S. Department of Health and Human Services

Class 1 Device Recall ExactaMix 2400

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  Class 1 Device Recall ExactaMix 2400 see related information
Date Initiated by Firm June 27, 2007
Date Posted September 27, 2007
Recall Status1 Terminated 3 on December 07, 2007
Recall Number Z-1238-2007
Recall Event ID 38372
Product Classification Pharmacy compounding system - Product Code NEP
Product Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
Code Information Version 1.07 of the EM2400 Operating Software. (Serial Numbers: 36805,36806,36356,36399,36804,36799,36797,36398,32438,36798,36460,36794,32346,36800,36801,36802,36803,(37767-36773), (36788-36793),36795 and 36796 (foreign)
Recalling Firm/
Manufacturer		 Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact
303-617-2242
Manufacturer Reason
for Recall		 A software defect could allow up to 50mL of extra volume being added to a TPN solution.
FDA Determined
Cause 2		 Other
Action All customers were notified via telephone on 06/27/2007 with follow-up of a faxed/emailed Urgent Product Recall letter dated 27 June 2007, detailing the software defect. End users were given a work around procedure to use until conversion back to version 1.06 could be scheduled. An additional copy of the recall letter was sent by FedEx.
Quantity in Commerce 30 units
Distribution Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK
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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