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  5. Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components
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Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

Illustration of the devices. H938173, non-vented high volume inlet. H938174, vented high volume inlet. H938175, vented micro volume inlet. H938176, micro volume inlet with luer lock end.
  • Product Names: Automated Compounding Device Inlets (disposable inlet) used with the ExactaMix and ExactaMix Pro
Product Code UDI Number Product Names Lot Numbers
H938173 00085412475783 Automated Compounding Device Inlet. Non- Vented, High-Volume Inlet See Full list of Affected Devices
H938174 00085412475790 Automated Compounding Device Inlet. Vented, High-Volume Inlet See Full list of Affected Devices
H938175 00085412475806 Automated Compounding Device Inlet. Vented, Micro-Volume Inlet See Full list of Affected Devices
H938176 00085412475813 Automated Compounding Device Inlet. Syringe Inlet See Full list of Affected Devices

What to Do

  • Inspect disposable inlets before use, including the inlet primary packaging, tubing, connectors, and spikes.
  • Do not use the inlet if particulate matter is observed.

The ExactaMix and ExactaMix Pro compounding devices can continue to be used with inlets where no particulate matter is observed.

On August 20, 2024, Baxter Healthcare Corporation sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

Actions for Pharmacy and Clinical Staff

  • Inspect inlets before use, including the inlet primary packaging, tubing, connectors, and spikes, in accordance with the letter's instructions.
  • If particulate matter is observed, do not use the inlet.
    • Contact Baxter Corporate Product Surveillance to report the complaint and to arrange for the safe return of the product for further investigation.
      • Have Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when contacting Baxter. The product code and lot number can be found on the product pouch and carton.
  • If no particulate matter is observed, the inlet can be used.
    • Prime the inlet before use according to the instructions provided in the Priming and Verifying section of the ExactaMix and ExactaMix Pro compounder Operator's Manual.  Visually inspect for particulate matter during this priming process and do not use if any particulate matter is observed.
  • Visually inspect the finished solution in the patient bag for precipitates and particulates after compounding, per the Fulfilling the Order section in the ExactaMix and ExactaMix Pro compounder Operator's Manual.  If any particulate matter is observed do not use. It is recommended that more than one Health Care Professional inspect the final product (example a pharmacist during and after compounding,  and a nurse prior to delivery to a patient).
  • Use a minimum of 1.2 micron in-line filter during product administration
    • The American Society for Parenteral and Enteral Nutrition (ASPEN) recommends using a 1.2 microns in-line filter for administration of total nutrient admixtures (TNAs), dextrose-amino acid admixtures, and lipid injectable emulsion. If you are already using in-line filtration per ASPEN recommendation, no additional action is necessary.
    • Use a minimum 1.2 micron in-line filter for administration of any solution involving the use of the Compounding Device Inlets.  This could include TPN, but also cardioplegia, continuous renal replacement therapy, epidural and basic solutions.  Note that administration of some of these solutions may involve a filter smaller than 1.2 microns as part of standard practice.

Actions for Customers

  • Share this information with anyone who may interact with ExactaMix and ExactaMix Pro compounders and the products they produce (pharmacy and clinical staff).
  • Follow the steps for inspecting, priming and in-line filtration until an acceptable replacement is available.
  • If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on the Baxter customer portal even if you do not have any inventory. https://BaxterFieldActionCustomerPortal.onprocess.com
    • Log in to the portal using the account number listed in the reply form enclosed with the letter. Acknowledging receipt of this notification will prevent you from receiving repeat notices.
  • Forward a copy of this communication to any other facilities or departments that may have received this product through distribution.
  • Dealers, wholesalers, distributors/resellers, or original equipment manufacturers should notify customers of this Urgent Medical Device Correction in accordance with customary procedures and check the associated box on the customer portal.

Reason for Updates to Use Instructions

Baxter Healthcare Corporation is updating use instructions for Automated Compounding Device Inlets (disposable inlet) used with the ExactaMix and ExactaMix Pro due to increased reports of particulate matter found within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use. This issue only affects the disposable inlets and does not affect the ExactaMix or ExactaMix Pro compounder devices.

The use of affected product may cause serious adverse health consequences, including a blood clot in the lungs (pulmonary embolism), stroke, damage to small blood vessels and organs, other serious injuries, and death.

There have been no reported injuries and no reports of death.

Device Use

The ExactaMix and ExactaMix Pro Automated Compounding Device Inlet is a disposable part of the ExactaMix and ExactaMix Pro compounding devices. These devices are used in a pharmacy to combine (compound) several ingredients into one final solution. The inlets are not intended for direct patient hook-up and are only used with the ExactaMix or ExactaMix Pro Compounders.

Contact Information

Customers in the U.S. with questions about this recall should contact Baxter Healthcare Center for Service at 888-229-0001.

Full List of Affected Devices

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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