HIGH

Baxter Healthcare CLEARLINK CONTIN-FLO IV Solution Sets Recalled for Leaks (2025)

Baxter Healthcare recalled 1,167,120 CLEARLINK CONTIN-FLO IV Solution Sets nationwide after determining they may leak. The non-vented sets include three CLEARLINK Luer Activated Valves and a backcheck valve. Healthcare providers and patients should stop using these devices immediately and contact Baxter 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 solution sets deliver fluids and medications in clinical settings. The CLEARLINK CONTIN-FLO line is designed for non-vented use with specific valve configurations.

Why This Is Dangerous

Leakage from IV sets may lead to unintended fluid loss and potential safety concerns during administration.

Industry Context

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

Real-World Impact

Hospitals and clinics must identify affected lots, stop use, and coordinate with Baxter for instructions and remediation.

Practical Guidance

How to identify if yours is affected

  1. Check product code 2C8541.
  2. Inspect for UDI/DI 00085412071107.
  3. Review lot numbers listed (e.g., R25A17123, R25B21024, etc.).

Where to find product info

Packaging and device labeling should show the UDI/DI and lot numbers; visit the FDA recall page for details.

What timeline to expect

Refunds or replacements are typically processed within several weeks once verified.

If the manufacturer is unresponsive

  • Document all communications with Baxter.
  • Escalate to hospital procurement if supplier is unresponsive.
  • Consider contacting regulatory bodies if there is no resolution.

How to prevent similar issues

  • Verify packaging labels before use.
  • Maintain a recall contact list for medical devices.
  • Ensure inventory is checked against recall notices before use.

Documentation advice

Keep product codes, UDI/DI, lot numbers, purchase receipts, and all correspondence with Baxter for records.

Product Details

Product: CLEARLINK SYSTEM CONTIN-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541 Model numbers include UDI/DI 00085412071107 and listed lots Sold nationwide in the United States; states listed in recall notice Quantity recalled: 1,167,120 units Price: Not disclosed

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1,167,120 units recalled
  • Non-vented IV solution sets with Luer Activated Valves included
  • Udi/DI 00085412071107 and multiple Lot numbers listed
  • Product Code 2C8541
  • Case distributed across all listed US states

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIV administration set
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 00085412071107
R25A17123
R25B20048
R25B21024
R25B24093
+13 more
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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