Baxter recalls EXACTAMIX Inlet syringes (H938176) due to particulate matter in the sterile fluid path. Affected units sold with ExactaMix and ExactaMix Pro compounders. 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 syringes (product code H938176) used in pharmaceutical compounding devices because they may contain particulate matter in the sterile fluid path. This could lead to contamination of compounded medications, posing a risk to patient safety.
Particulate matter has been found in the sterile fluid path tubing of the EXACTAMIX Inlet syringes before use. This could contaminate compounded medications, potentially causing adverse effects in patients receiving the medication.
Pharmaceutical compounding professionals and healthcare facilities using Baxter EXACTAMIX Inlet syringes with ExactaMix or ExactaMix Pro compounders. Those who have the specific product codes H938173-H938176 are most at risk.
Check for product codes H938173, H938174, H938175, or H938176 on the syringe packaging. These units were sold with UDI/DI 00085412475813 and lot numbers 803807 and lower.
Identify if your syringe has product codes H938173, H938174, H938175, or H938176.
Reach out to Baxter Healthcare Corporation for further instructions on handling recalled units.
Baxter EXACTAMIX Inlet syringes with product codes H938173, H938174, H938175, or H938176 used in ExactaMix and ExactaMix Pro compounders.
Check for product codes H938173-H938176 on the syringe packaging, and lot numbers 803807 and lower with UDI/DI 00085412475813.
Contact Baxter Healthcare Corporation for instructions on handling the recalled units.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-3085-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-3085-2024 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.
