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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Baxter Healthcare
- Product type
- IV administration set
- Model numbers
- UDI/DI 00085412048970, R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017, R25C18024 +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 29, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
IV administration sets are used to deliver fluids and medications via IV lines in medical settings. The CLEARLINK CONTINU-FLO solution set is a non-vented configuration with three valves and a retractable collar.
Why This Is Dangerous
Leakage in IV sets can compromise fluid delivery and potentially expose patients to IV fluids or medications.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics distributing these units nationwide may need to replace affected sets to ensure safe IV therapy; 958,351 units were distributed.
Practical Guidance
How to identify if yours is affected
- Identify Baxter CLEARLINK CONTINU-FLO Solution Set, non-vented, product code 2C8537
- Check for three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch length
- Verify UDI/DI 00085412048970 and listed model numbers
Where to find product info
FDA recall page linked in the notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0193-2026
What timeline to expect
Typically 4-8 weeks for refunds or replacements
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to Baxter support
- File a complaint with FDA if no action after 4 weeks
How to prevent similar issues
- Verify IV sets against recall lists prior to use
- Check product code and model numbers during procurement
- Request replacements or refunds through the recall program
- Do not reuse single-use IV sets
Documentation advice
Keep the recall notice, model numbers, date codes, and all correspondence with Baxter or suppliers
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Product Details
Model numbers and product code: 2C8537. UDI/DI 00085412048970. Model numbers include R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017, R25C18024, R25C25116, R25C26093, R25C31079, R25D03055, R25D12123, R25D19024. Sold nationwide in the US through hospitals and medical facilities. Sold since unspecified date. Product Code 2C8537. Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code 2C8537
- Non-vented IV sets with Luer Activated Valves may leak
- Distributed nationwide in the US
- Model list includes 14 items (see above)
- No injuries or incidents reported at this time
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Safety Guide
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