HIGH

Baxter Healthcare Recalls IV Extension Sets Over Leak Risk

Baxter Healthcare recalled 15,552 IV extension sets on August 29, 2025, due to a leak risk. The recall affects products distributed nationwide across 50 states. Healthcare providers and patients must stop using the 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 recalled product is the CLEARLINK SYSTEM EXTENSION SET with product code 2C8610. These IV extension sets measure 44 inches and feature a Luer activated valve and retractable collar. They were distributed nationwide in the United States.

The Hazard

The IV extension sets may leak, posing a significant risk to patients. This issue falls under Class II recall, indicating a moderate risk of injury.

Reported Incidents

There have been no specific reports of injuries or incidents mentioned related to the recalled IV extension sets. However, the potential for leakage raises serious concerns.

What to Do

Stop using the recalled IV extension sets immediately. Patients and healthcare providers should follow the recall instructions provided by Baxter Healthcare Corporation.

Contact Information

For further information, contact Baxter Healthcare Corporation or your healthcare provider. More details about the recall can be found at the FDA website.

Key Facts

  • IV extension set model: CLEARLINK SYSTEM EXTENSION SET
  • Product code: 2C8610
  • Quantity recalled: 15,552 units
  • Recall date: August 29, 2025
  • Hazard: IV sets may leak
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 Extension Set
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 00085412048963
Lot numbers: R25C31024
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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