Tue Sep 24 04:00:00 UTC 2024: ## Baxter Healthcare Issues Urgent Recall for ExactaMix Compounding Device Inlets

**[City, State] -** Baxter Healthcare Corporation has issued a Class I recall for Automated Compounding Device Inlets (disposable inlets) used with its ExactaMix and ExactaMix Pro compounding devices. The recall, deemed the most serious type by the FDA, is due to increased reports of particulate matter found within the inlet components, including within the sterile fluid path tubing, before use.

While the ExactaMix and ExactaMix Pro compounder devices themselves are not affected, the use of contaminated inlets poses a serious health risk, potentially leading to blood clots, stroke, organ damage, and even death.

**The recall does not involve removing the devices from use or sale.** Instead, Baxter Healthcare is updating the use instructions for the inlets. Customers are advised to use inlets where no particulate matter is observed and to refer to the updated instructions for proper usage.

The company has sent an Urgent Medical Device Correction letter to all affected customers, recommending they:

* Review the updated instructions.
* Stop using any inlets exhibiting particulate matter.
* Contact Baxter Healthcare Center for Service at 888-229-0001 for any questions.

The FDA encourages healthcare professionals and consumers to report any adverse reactions or quality problems experienced using these devices to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

This recall highlights the importance of the unique device identifier (UDI), which helps track medical devices and allows for quicker identification and correction of potential problems.

**To stay informed on medical device recalls and safety information, sign up for email updates from the FDA.**

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