HIGH

Baxter Healthcare Recalls IV Solution Set Due to Leak Risk

Baxter Healthcare recalled 49,200 IV solution sets on August 29, 2025. The recall affects products that may leak, posing a risk 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

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Product Details

The recalled product is the CONTINU-FLO Solution Set, Non-Vented, featuring two CLEARLINK Luer Activated Valves and a Backcheck Valve. The affected model codes include UDI/DI 00085412046310 and lot numbers R25C26161 and R25D01031.

The Hazard

The IV solution sets may leak, which can pose serious health risks to patients receiving intravenous therapy. This recall falls under Class II, indicating a potential for temporary or medically reversible adverse health consequences.

Reported Incidents

As of the recall date, no specific incidents or injuries have been reported. The potential for leaks raises concerns for patient safety.

What to Do

Stop using the recalled IV solution sets immediately. Follow the recall instructions provided by Baxter Healthcare and contact your healthcare provider for further guidance.

Contact Information

For more information, contact Baxter Healthcare Corporation directly. Visit their website or call their customer service for instructions regarding the recall.

Key Facts

  • Recall date: August 29, 2025
  • Quantity: 49,200 units
  • Class II recall
  • Affected states: All US states
  • Manufacturer: Baxter Healthcare

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Safety Assessment

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

Product Details

Model Numbers
UDI/DI 00085412046310
Lot numbers: R25C26161 and R25D01031
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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