HIGH

Baxter Healthcare Recalls 49,200 CONTINU-FLO IV Solution Sets for Leakage Risk (2025)

Baxter Healthcare recalls 49,200 CONTINU-FLO IV Solution Sets distributed nationwide in the United States. IV sets may leak. Healthcare facilities and patients should stop using the device immediately and follow Baxter's recall instructions.

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, 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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About This Product

CONTINU-FLO Solution Set is a non-vented IV administration set with CLEARLINK valves used for delivering intravenous therapies.

Why This Is Dangerous

Leakage at connections or valves can cause unintended fluid leakage during IV administration, potentially compromising therapy.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics using these sets may need to halt use, inspect inventory, and coordinate with Baxter for remediation; no injuries reported yet.

Practical Guidance

How to identify if yours is affected

  1. Identify the device as CONTINU-FLO Solution Set with two CLEARLINK Luer Activated Valves and a Backcheck Valve.
  2. Check for UDI/DI 00085412046310 on the label.
  3. Check for lot numbers R25C26161 or R25D01031 on the packaging or device.
  4. If any match, treat as affected and follow recall instructions.

Where to find product info

Recall information is available on the FDA enforcement page linked in the article and Baxter's recall communications.

What timeline to expect

Refunds or replacements typically take 4-8 weeks after initiation.

If the manufacturer is unresponsive

  • Document all contact attempts with Baxter Healthcare Corporation.
  • Consider contacting the FDA or local health authorities if responses are slow.

How to prevent similar issues

  • Purchase IV sets only from authorized medical distributors.
  • Verify device identifiers before use in clinical settings.
  • Maintain a current inventory log to quickly identify recalled lots.

Documentation advice

Keep copies of the recall notice, labels, model numbers, serials, Lot numbers, photos, and all correspondence with Baxter or healthcare providers.

Product Details

Brand: Baxter Healthcare. Product: CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve. Product code: 2C6255. Model numbers/Lot numbers: UDI/DI 00085412046310; Lot numbers R25C26161 and R25D01031. Sold in: United States nationwide. Sold since: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 49,200 units recalled nationwide in the US
  • Product code 2C6255
  • Model: UDI/DI 00085412046310; Lot numbers R25C26161, R25D01031
  • Hazard: IV sets may leak

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Details

Model Numbers
UDI/DI 00085412046310
R25C26161
R25D01031
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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