HIGH

Baxter recalls 2,304 CLEARLINK IV Extension Sets for leak risk in 2025

Baxter Healthcare recalled 2,304 CLEARLINK System Extension Sets distributed nationwide in the United States. The IV extension set may leak, creating a risk to patients. Stop using the device immediately and follow recall instructions from Baxter or your healthcare provider.

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

CLEARLINK System Extension Set is used in IV therapy to extend IV lines. It connects to IV catheters to deliver fluids. The set includes a Luer activated valve and retractable collar for connection and control.

Why This Is Dangerous

Leakage can lead to unintended IV fluid leakage, potential contamination, and infection risk. Leakage can also compromise medication delivery to patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

High risk to patients if leakage occurs during IV therapy. Hospitals and clinics may face supply disruption and increased safety checks.

Practical Guidance

How to identify if yours is affected

  1. Check UDI/DI 00085412049007 on the device label.
  2. Check Lot number R25C31031 on packaging or device label.
  3. Verify Product Code 2C8632 and 14-inch length.

Where to find product info

UDI/DI and Lot numbers are on the product label and packaging. The FDA recall page provides official instructions.

What timeline to expect

4-8 weeks for refunds or replacements, depending on Baxter’s process.

If the manufacturer is unresponsive

  • Document all attempts to contact Baxter and recall notifications.
  • escalate to FDA/ CPSC recall channels if needed.
  • Consider seeking legal advice for unresolved safety concerns.

How to prevent similar issues

  • Verify recall status before purchasing IV extension sets.
  • Purchase from authorized distributors.
  • Keep an updated list of recalled lots and models.

Documentation advice

Save recall notices, take photos of labels, log communication with Baxter, and retain receipts or invoices.

Product Details

Model/Code: 2C8632; UDI/DI: 00085412049007; Lot: R25C31031. Quantity: 2304 units. Sold nationwide in the United States.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 2304 units recalled
  • Leak hazard in CLEARLINK System Extension Set
  • Model/UDI: 00085412049007; Lot: R25C31031
  • Recall status: ACTIVE as of 2025-10-22
  • Sold nationwide in the US

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 Classification

Product Details

Model Numbers
UDI/DI 00085412049007
Lot numbers: R25C31031
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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