HIGH

Baxter Healthcare Recalls IV Solution Sets Due to Leakage Risk

Baxter Healthcare recalled 958,351 IV solution sets on August 29, 2025. The products may leak, posing a high risk to patients. Healthcare providers and patients must 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 recall involves CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, with product code 2C8537. The affected models include multiple lot numbers, such as R25A13055 and R25B24024. The products were distributed nationwide in the U.S.

The Hazard

The recalled IV sets may leak, which could lead to serious complications for patients. Leakage can compromise the delivery of medications or fluids, potentially resulting in adverse health effects.

Reported Incidents

There are no specific injury reports or incidents mentioned related to this recall. However, the potential for leakage presents a high risk to patient safety.

What to Do

Patients and healthcare providers should stop using the recalled IV solution sets immediately. Contact Baxter Healthcare Corporation or your healthcare provider for further instructions and follow the provided recall guidelines.

Contact Information

For more information, contact Baxter Healthcare Corporation at [phone number not provided]. Visit their website for recall instructions: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0193-2026.

Key Facts

  • Recall date: August 29, 2025
  • Total quantity recalled: 958,351 units
  • Risk level: High
  • Affected states: Nationwide distribution in the U.S.

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Safety Assessment

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

Product Details

Model Numbers
UDI/DI 00085412048970
R25A13055
R25B24024
R25B25154
R25C05017
+9 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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