Class 2 Device Recall AUTOMIX 33

• Date Initiated by Firm: January 27, 2011
• Date Posted: February 22, 2011
• Recall Status: Terminated on February 16, 2012
• Recall Number: Z-1385-2011
• Recall Event ID: 57790
• 510(K)Number: K894827
• Product Classification: Set, i.V. Fluid transfer - Product Code LHI
• Product: AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015; 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 codes 2M8286 and 2M8286K, 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: The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from host software (MAN ID Mode). It is possible that an incorrect volume and/or an incorrect solution could be admixed into the final bag.
• FDA Determined Cause: Other
• Action: Baxter Healthcare Corp. sent Urgent Device Correction letters dated January 27, 2011, via first class mail to all affected customers. informing personnel that use Automix compounders to exercise care when entering data, and verify the accuracy of the keypad response. The accounts were requested to convey this information to all users of the Automix compounders, emphasizing the need to verify data accuracy each time the keypad is used. The accounts 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. After determining the root cause of the incorrect keypad responses, Baxter issued a follow-up correction letter on 4/27/11 outlining the recommended work practices to reduce fluid penetration into the Automix compounder keypad/control module.
• Quantity in Commerce: 3100 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.

• 510(K) Database: 510(K)s with Product Code = LHI and Original Applicant = BAXTER HEALTHCARE CORP.