Baxter recalls EXACTAMIX Inlet (H938175) for particulate matter in pharmaceutical compounding devices. Affected units include specific lot numbers and product codes. Stop using if you have these items.
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Baxter is recalling EXACTAMIX Inlet components (product codes H938173-H938176) due to observed particulate matter in the sterile fluid path. This could contaminate pharmaceutical compounds during use, posing a risk to patient safety.
Particulate matter has been found inside the sterile fluid path tubing of the inlets before use. This could lead to contamination of compounded medications, potentially harming patients during pharmaceutical preparation.
Pharmaceutical compounding users who own or use the recalled EXACTAMIX Inlet components (product codes H938173-H938176) are affected. Healthcare professionals handling medications with these inlets are most at risk.
Check for product codes H938173, H938174, H938175, or H938176 on the inlets. Affected units have lot numbers 803808 and lower, with UDI/DI 00085412475806.
Identify if your EXACTAMIX Inlet has product codes H938173, H938174, H938175, or H938176.
Confirm if your inlet has lot numbers 803808 or lower, as these are affected units.
Baxter has received reports of particulate matter in the sterile fluid path tubing of these inlets, which could contaminate compounded medications.
The recall record does not specify a remedy, so contact Baxter Healthcare Corporation directly for guidance.
Particulate matter in the sterile fluid path could lead to medication contamination, but the recall does not indicate immediate harm to users.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-3084-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-3084-2024 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
