Class 2 Device Recall ExactaMix 2400 Valve Set

• Date Initiated by Firm: July 14, 2022
• Date Posted: August 24, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1570-2022
• Recall Event ID: 90643
• 510(K)Number: K002705
• Product Classification: Set, i.V. Fluid transfer - Product Code LHI
• Product: The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
• Code Information: Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-948-9837
• Manufacturer Reason for Recall: There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
• FDA Determined Cause: Process control
• Action: Baxter issued an URGENT DEVICE CORRECTION notice by mail on 07/14/2022. Baxter sent a follow-up notice dated 6/28/2023, stating Customers may return to using all 24 ports on their compounders when using newly manufactured EXACTAMIX 2400 Valve Sets (product code H938724, lot 60459942 and sequentially higher). Contact Baxter Technical Support M-F 8am-7pm ET at 800-678-2292 for help establishing/restoring a 24-port configuration for compounding, if not on drop-down menu. Lot numbers 60459941 and lower MUST use only 20 ports, omitting ports 1-4. For these sets: Baxter Technical Service added new compounder configurations for temporary use that omit the use of ports 1-4, and only use ports 5-24 for the ingredients on your compounder. For valve sets Lot numbers 60459941 and lower, a maximum of 20 ingredients can be pumped via the compounder. Observe the pumping process to monitor for leaks and unintended white or yellow discolored solution pumping through the valve set tubing into the final container. If unintended transfer of solutions from ports 1-4 are seen, abort the compounding process, discard the final container, replace the valve set, and report the incident to Baxter Product Surveillance. Depending on the ingredients on ports 1-4 and the respective volumes, customers may be able to add these ingredients as manual additions. Consider the type of ingredient to avoid precipitation based on the sequence of those additions. Continue to follow your institutional policy and procedures for compounding. The use of a 1.2-micron filter is a recommended best practice by ASPEN when administering all parenteral nutrition formulations.
• Quantity in Commerce: 448,960 units
• Distribution: Worldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil, Colombia, Dominican Republic, Panama, Puerto Rico, Hong Kong, Taiwan, Korea, United Kingdom, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Kuwait, Netherlands, Oman, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LHI