FDA recall: Updated instructions for compounding device inlets

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The FDA’s Center for Veterinary Medicine has announced Baxter Healthcare Corporation’s updates to the instructions for use of Automated Compounding Device Inlets (disposable inlets) used with the ExactaMix and ExactaMix Pro.¹ The updates come in response to increased reports of particulate matter found within the inlet primary packaging inlet components, including in the sterile fluid path tubing, prior to use.^1,2 The issue only affects the disposable inlets, and not the ExactaMix or ExactaMix Pro compounder devices. The FDA identified this recall as the most serious type, with the potential to cause serious injury or death with continued use without consideration for the updated instructions.¹

The recall recommends the inspection of disposable inlets prior to use, including inlet primary packaging, tubing, connectors, and spikes. If particulate matter is noted during inspection, the inlet should not be used. The compounding devices can continue to be used with inlets when no particulate matter is found.

Specific Automated Compounding Device Inlets affected by the recall:²

• Non-vented, high-volume inlet (for bags or vented bottles); Product code: H938173
• Vented, high-volume inlet (for non-vented bottles); Product Code: H938174
• Micro-volume inlet (for small bottles); Product Code: H938175
• Micro-volume syringe inlet with luer lock end; Product Code: H938176

On August 20, 2024, Baxter Healthcare Corporation sent Urgent Medical Device Correction letters to all affected customers.³ In the letters, affected pharmacy and clinical staff were advised to complete thorough inspections of the inlets. Staff could still use inlets when no particulate matter was observed. They should prime inlets prior to use according to the instructions provided in the device’s operator’s manual, simultaneously screening for the presence of any particulate matter, stopping the process when it is observed.^2,3

In the instance that particulate matter is observed during inspection, staff are advised to contact Baxter Corporate Product Surveillance to report the complaint and arrange for the safe return of the product. Staff should be prepared with the product code and lot number (both of which can be found on the product pouch and carton), in addition to the Baxter 8-digit ship-to account number, and quantity of items to be returned when contacting Baxter.^2,3

The letter further recommended the visual inspection of the finished solution in patient bags for precipitates and particulates after compounding by more than 1 health care professional, refraining from use if particulate matter is observed, as directed in the operator’s manual. Additionally, a minimum of 1.2 micron in-line filter should be used during administration of total nutrient admixtures (TNAs), dextrose-amino acid admixtures, and lipid injectable emulsion, as recommended by the American Society for Parenteral and Enteral Nutrition (ASPEN). The minimum of 1.2 micron in-line filter applies to the administration of any solution involving the use of the compounding device inlets, which could include total parenteral nutrition (TPN), cardioplegia, continuous renal replacement therapy, epidural, and basic solutions.³

The letter advises that clients share information regarding the updated instructions with anyone who may interact with ExactaMix and ExactaMix Pro compounders. Continued use of the products without consideration for updated instructions may result in pulmonary embolism, stroke, damage to small blood vessels and organs, other serious injuries, and death.^1,2

References

1. Recall of Certain Compounding Device Inlets Potentially Used in Veterinary Settings. US Food and Drug Administration. September 24, 2024. Accessed September 25, 2024. https://content.govdelivery.com/accounts/USFDA/bulletins/3b7db1d
2. 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. US Food and Drug Administration. September 24, 2024. Accessed September 25, 2024. https://www.fda.gov/medical-devices/medical-device-recalls/compounding-device-inlet-correction-baxter-healthcare-corporation-updates-use-instructions-exactamix?utm_medium=email&utm_source=govdelivery
3. Urgent Medical Device Correction. Baxter Healthcare Corporation. August 20, 2024. Accessed September 25, 2024.