Class 2 Device Recall Baxa ExactaMix 2400 Pharmacy compounding system.

• Date Initiated by Firm: February 11, 2008
• Date Posted: August 19, 2008
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-1370-2008
• Recall Event ID: 46771
• Product Classification: Automated pharmacy compounding system - Product Code NEP
• Product: Exacta-Mix 2400, 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: Models 2400-D, 2400-M, 2400-L, 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: 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: 1000 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.