Class 1 Device Recall ExactaMix 2400

• Date Initiated by Firm: June 27, 2007
• Date Posted: September 27, 2007
• Recall Status: Terminated 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: 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.