Baxter recalls EXACTAMIX Inlet (H938174) for particulate matter in pharmaceutical compounding devices. Affected units include specific lot numbers and product codes. Consumers should check their units and contact Baxter for details.
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 inlet's sterile fluid path tubing before use. This could introduce contaminants into pharmaceutical compounds during compounding, potentially affecting product safety.
Pharmaceutical compounding professionals and facilities using Baxter EXACTAMIX Inlets with ExactaMix or ExactaMix Pro compounders. Those with specific lot numbers (803799 and lower) are most at risk.
Check for product codes H938173 to H938176 on the inlet. Look for lot numbers 803799 and lower on the packaging. These inlets are used with ExactaMix or ExactaMix Pro compounders.
Identify the product code and lot number on the Baxter EXACTAMIX Inlet packaging to confirm if it is affected.
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, product codes H938173-H938176, with lot numbers 803799 and lower.
Baxter has received reports of particulate matter in the sterile fluid path tubing of these inlets before use, which could contaminate pharmaceutical compounds.
Check the product code and lot number. If affected, contact Baxter for further instructions.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-3083-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-3083-2024 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.
