HIGH

Baxter Healthcare Recalls IV Infusion Sets Due to Leak Risk

Baxter Healthcare recalled 27,072 IV infusion sets on August 29, 2025, due to potential leaks. The affected product, model code 2R8858, may pose significant risks to patients. Healthcare providers and patients should stop using these devices immediately.

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

Product Details

The recall involves the CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing. It includes a CLEARLINK Luer Activated Valve and a 0.2 Micron Filter, with a length of 107 inches (2.7 meters). These devices were distributed nationwide in the United States.

The Hazard

The recalled IV sets may leak, posing a risk of inadequate drug delivery or exposure to the drug. This issue falls under Class II, indicating a potentially harmful situation.

Reported Incidents

As of now, there have been no reported injuries or deaths linked to the recalled IV sets. The leak could result in serious health complications if not addressed.

What to Do

Stop using the recalled IV infusion sets immediately. Contact Baxter Healthcare Corporation or your healthcare provider for further instructions on the recall.

Contact Information

For more information, visit the recall notice at the FDA website or contact Baxter Healthcare Corporation directly.

Key Facts

  • Recalls 27,072 IV infusion sets
  • Leak risk identified
  • Affected model code: 2R8858
  • Nationwide distribution in the U.S.
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeIV Infusion Set
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 00085412565774
Lot numbers: R25A13024
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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