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U.S. Department of Health and Human Services

Class 2 Device Recall ExactaMix 2400 Valve Set

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  Class 2 Device Recall ExactaMix 2400 Valve Set see related information
Date Initiated by Firm July 14, 2022
Create Date August 24, 2022
Recall Status1 Open3, 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.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm notified its consignees by issuing an UPGENT DEVICE CORRECTION notice by mail on 07/14/2022. The notice request the following actions be taken: "Actions to be Taken by Customers: Baxter currently has significant supply constraints for our EXACTAMIX Valve Sets required for the EXACTAMIX Automated Compounding Device. Therefore, we are recommending the following actions: 1. Please call Baxter at 888-608-9898, between the hours of 8:00 am and 7:00 pm Eastern Time, Monday through Friday, to schedule an appointment for a device correction that will add new compounder configurations. You will require setup of new compounder configurations that omit the use of ports 1-4, and only use ports 5-24 for the ingredients on your compounder. During the device correction period, a maximum of 20 ingredients will be able to be pumped via the compounder. 2. Customers may continue compounding with affected valve sets during the device correction period, including any valve sets that were set aside by customers pending Baxter s investigation of this leak issue, provided those valve sets have remained in their original unopened packages, were stored in accordance with the instructions for use, and are not expired. Baxter recommends customers observe the pumping process to monitor for leaks. Leaks have been reported on ports 1 and 2 when in the closed position, where standard EXACTAMIX configurations have lipids (white opaque colored) and multi-vitamin (yellow colored) ingredients. Additionally, port 3 is also designated for multi-vitamin ingredients. Baxter recommends customers observe the pumping process to ensure they do not see 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 noted during the compounding process, the user should abort the compounding process, discard the final container, replace the valve set, and report the incident to Baxter Product Surveill
Quantity in Commerce 113,840 units
Distribution US Nationwide distribution.
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 and Original Applicant = BAXA CORP.
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