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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Baxter Healthcare Corporation 2024-09-25 Health critical FDA
Health · FDA · Recall #FDA-Z-3085-2024

Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical… Recall

Issued September 25, 2024 · Baxter Healthcare Corporation

In September 2024, Baxter Healthcare Corporation recalled the Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Baxter Healthcare Corporation to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Baxter Healthcare Corporation
Category
Health
Recall date
September 25, 2024
Units affected
Not reported
Sold at
Worldwide distribution.
Recall number
FDA-Z-3085-2024
Made in
United States
Issuing agency
FDA

In context

  • Baxter Healthcare Corporation has 36 recalls in our database, including 5 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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