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EXACTAMIX recallZ-1570-2022 · Baxter Healthcare Corporation · initiated Jul 14, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1570-2022
Status
Open, Classified
Initiated by the company
Jul 14, 2022
Posted by the FDA
Aug 24, 2022
Recalling firm
Baxter Healthcare Corporation
Quantity
448,960 units
Product code
LHI
FDA submissions
K002705
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.

Product description

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 (models, lots, serial numbers)

Product Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K002705 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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