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U.S. Department of Health and Human Services

Class 2 Device Recall Baxa ExactaMix 600 Pharmacy compounding system

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  Class 2 Device Recall Baxa ExactaMix 600 Pharmacy compounding system see related information
Date Initiated by Firm February 11, 2008
Date Posted August 19, 2008
Recall Status1 Terminated 3 on March 16, 2012
Recall Number Z-1371-2008
Recall Event ID 46771
Product Classification Automated pharmacy compounding system - Product Code NEP
Product Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.
Code Information Model 071B-RS232, all serial numbers
Recalling Firm/
Manufacturer		 Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact
303-617-2242
Manufacturer Reason
for Recall		 Flush solution from TPN compounder may be added to patient's TPN bag.
FDA Determined
Cause 2		 Software design
Action Consignees were notified by letter (Exacta-Mix Compounder Software Safety Alert) on 02/11/2008 advising them of the necessity to install a waste bag prior to a machine flush.
Quantity in Commerce 221 units
Distribution Nationwide, including military facilities in CA, FL, HI, MS, NC, TX, VA and VA facilities in NY, OR, SC, UT. Foreign distribution to Australia, Canada, China and New Zealand.
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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