HIGH

Baxter Healthcare Recalls 18,720 CLEARLINK Non-DEHP IV Sets for Leakage Risk (2025)

Baxter Healthcare Corp. is recalling 18,720 CLEARLINK System Non-DEHP Conti-Flo Soln Sets sold nationwide in the United States. The IV sets may leak, potentially compromising therapy. Patients and healthcare providers should stop using the device immediately and contact Baxter Healthcare for instructions.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
Baxter Healthcare
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

IV sets may leak.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions

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About This Product

IV sets deliver fluids and medications through a patient’s vein. They are used in clinical settings by healthcare professionals.

Why This Is Dangerous

Leakage from an IV set could compromise the sterile delivery of IV fluids and medications, necessitating device replacement.

Industry Context

This recall is not stated as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics may need to replace affected sets, causing logistical and workflow disruptions and potential treatment delays.

Practical Guidance

How to identify if yours is affected

  1. Verify product label shows CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET
  2. Confirm length 96 inches (2.4 m)
  3. Check Product Code 2H8519
  4. Inspect UID/DI 00085412625553 on the label
  5. Check Lot number R25C08147 on packaging

Where to find product info

Look on device labeling and packaging for UID/DI and Lot number details.

What timeline to expect

Refunds or replacements are typically processed within 4-6 weeks after verification.

If the manufacturer is unresponsive

  • Document all outreach attempts to Baxter
  • Escalate to a healthcare administrator or regulatory body if needed
  • Consider filing a report with the relevant authority if no response

How to prevent similar issues

  • Verify DEHP-free status before purchasing IV sets
  • Request non-DEHP alternatives from suppliers
  • Check for recalls before using new lots or product codes

Documentation advice

Keep the recall notice, packaging, labels, receipts, and all correspondence with Baxter for records.

Product Details

Model numbers: UID/DI 00085412625553; Lot numbers: R25C08147; Product Code: 2H8519; Length: 96 inches (2.4 m); Units recalled: 18,720; Distribution: U.S. nationwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 18,720 units recalled
  • Product Code 2H8519
  • UID/DI 00085412625553 on label
  • Lot R25C08147 on packaging
  • Length 96 inches (2.4 m)
  • US nationwide distribution

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UID/DI 00085412625553
Lot R25C08147
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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