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Serious recall: Injury is possible or has been reported. Take action promptly.

Baxter Healthcare Corporation 2025-10-22 Health serious FDA
Health · FDA · Recall #FDA-Z-0194-2026

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated… Recall

Issued October 22, 2025 · Baxter Healthcare Corporation

In October 2025, Baxter Healthcare Corporation recalled the CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated…, a serious 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

IV sets may leak.

What you should do

  1. 1 Stop using CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated… 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
October 22, 2025
Units affected
Not reported
Sold at
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN
Recall number
FDA-Z-0194-2026
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 691st Health recall we've logged in 2025.
Read the official FDA notice

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