HIGH

Baxter CLEARLINK Paclitaxel IV Set Recalled for Leak Hazard in 2025 (27,072 Units)

Baxter Healthcare recalled 27,072 CLEARLINK System Paclitaxel IV Sets distributed nationwide in the United States. The units may leak. Hospitals and clinics should stop using the device immediately and follow Baxter’s recall instructions. Contact Baxter or your healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
Baxter
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

The CLEARLINK Paclitaxel IV Set is used to administer chemotherapy via IV. It features non-vented tubing and a CLEARLINK Luer Activated Valve with a 0.2 micron filter and 107-inch tubing.

Why This Is Dangerous

Leaks at the infusion set can cause unintended leakage and improper drug delivery, potentially exposing healthcare workers and patients to chemotherapy agents.

Industry Context

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

Real-World Impact

Hospitals may need to quarantine affected lots and switch to approved devices. No patient injuries are cited in the notice.

Practical Guidance

How to identify if yours is affected

  1. Verify product code 2R8858 on the device label
  2. Check UDI/DI 00085412565774
  3. Confirm lot number R25A13024
  4. Ensure tubing length is 107 inches and features 0.2 micron filter with non-vented design

Where to find product info

Product labels, package inserts, and recall notice. The recall page provides official identifiers.

What timeline to expect

No public timeline is provided. Hospitals should follow Baxter instructions and monitor for updates.

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • File a report with Baxter recall team
  • If needed, contact FDA recall hotlines or regional authorities for assistance

How to prevent similar issues

  • In future purchases, verify device identifiers before stocking
  • Maintain a current list of approved vendors and recall statuses
  • Institute standard testing for leak-prone infusion sets before deployment

Documentation advice

Keep a copy of the recall notice, store device identifiers, document all correspondence with Baxter and distributors, and record replacement status

Product Details

Product: CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, 10 drops/mL, 107-inch (2.7 m) tubing. Product Code 2R8858. UDI/DI 00085412565774. Lot numbers: R25A13024. Quantity: 27,072 units. Sold nationwide in the US via healthcare distributors.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 27,072 units recalled
  • Product Code 2R8858
  • UDI/DI 00085412565774
  • Lot R25A13024
  • 107-inch tubing length
  • Non-vented with polyethylene-lined tubing

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

Brand
Model Numbers
UDI/DI 00085412565774
Lot R25A13024
Product Code 2R8858
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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