Class 1 Device Recall AUTOMIX 3 3/AS

• Date Initiated by Firm: July 13, 2012
• Date Posted: August 08, 2012
• Recall Status: Terminated on August 11, 2017
• Recall Number: Z-2142-2012
• Recall Event ID: 62558
• Product Classification: System/device, pharmacy compounding - Product Code NEP
• Product: AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; ; ; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
• Code Information: Product code 2M8287, all serial numbers
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.
• FDA Determined Cause: Device Design
• Action: Baxter Healthcare Corp. sent an Urgent Product Recall letters dated July 13, 2012, via first class mail to all affected customers, informing personnel that Baxter was executing a voluntary controlled product withdrawal of the Automix system from the U.S. market by June 1, 2013. Until their units can be replaced, customers were advised to exercise care when entering data, and verify the accuracy of the keypad response; to inspect the umbilical cable of the Automix for any visible cuts, nicks deformation, or physical damage to the cable, discontinuing use of the device if such damage is found; and to return the device to Baxter if the device stops compounding without an alarm and without a visible green complete light, discarding the solution bag. The customers were requested to convey this information to all users of the Automix compounders, and a wall chart was provided to hang over the device to remind users of the mitigations to take. The customers were also requested to complete the attached customer reply form listing the model and serial number of each of the Automix compounders at the facility and confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to their local Baxter representative, and technical questions were directed to Baxter's Global Technical Services at 1-800-626-2667.
• Quantity in Commerce: 950 units
• Distribution: Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom.
• 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.