The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in t

FDA device recall Z-1570-2022 · posted 2022-08-24 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

LHI

Quantity affected

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

Date initiated

2022-07-14

Date posted

2022-08-24

Location

Deerfield, IL

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