The Recall Desk
SevereFDA (Devices)·Z-3082-2024·Announced 2024-09-25

Baxter EXACTAMIX Inlet Compounders Recalled for Particulate Matter Contamination

Baxter Healthcare is recalling EXACTAMIX Inlet components (H938173 and related codes) due to particulate matter contamination observed in the sterile fluid path before use. Approximately 3.58 million units distributed worldwide are affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification per agency determination. Per rubric, FDA Class I recalls never score below 4, as they indicate hazards that could cause serious adverse health consequences.

Plain-English summary

Baxter Healthcare Corporation is recalling disposable inlet components for the ExactaMix and ExactaMix Pro pharmaceutical compounding devices. Affected product codes include H938173, H938174, H938175, and H938176.

Particulate matter has been observed inside the inlet components, including within the sterile fluid path tubing, before use. The company has received increased customer reports of this contamination.

Approximately 3,580,283 units have been distributed worldwide. Affected lot numbers are 803806 and lower, with UDI/DI 00085412475783.

The recalled product

Product
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Compounding Device Inlet
Hazard
  • particulate-matter

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 00085412475783
  • Lot Numbers: 803806 and lower

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category