HIGH

Baxter Healthcare Recalls IV Sets Due to Leakage Risk

Baxter Healthcare recalled 12,720 CONTINU-FLO Solution Sets on August 29, 2025, due to a risk of leakage. The recall affects various states across the U.S. Healthcare providers and patients must stop using the product 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 CONTINU-FLO Solution Set, Non-Vented, with three CLEARLINK Luer Activated Valves and a Backcheck Valve. It has a drop rate of 10 drops/mL and a length of 120 inches (3.0 meters). The product code is 2R8537.

The Hazard

The recalled IV sets may leak, which can pose a risk of infection or inadequate medication delivery. This risk categorizes the recall as Class II, indicating a potential but not immediate threat to health.

Reported Incidents

As of now, no specific incidents or injuries related to this leakage have been reported. The risk of leakage could lead to serious health complications if not addressed.

What to Do

Stop using the affected IV sets immediately. Follow the recall instructions provided by Baxter Healthcare Corporation. Contact your healthcare provider for further guidance.

Contact Information

For more information, contact Baxter Healthcare Corporation or visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0202-2026.

Key Facts

  • Product Code: 2R8537
  • Quantity Recalled: 12,720 units
  • Hazard: IV sets may leak
  • Recall Date: August 29, 2025
  • Contact Baxter Healthcare for further instructions
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIV Set
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 00085412565743
Lot numbers: R25C28048
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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