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, PREGNANT
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 Extension Set
- Model numbers
- UDI/DI 00085412048963, Lot R25C31024
- Sizes
- 44-inch (111 cm)
- 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
CLEARLINK SYSTEM EXTENSION SET is a sterile IV extension used to connect IV lines and extend reach. It is part of routine IV therapy in clinical settings.
Why This Is Dangerous
A leak in the IV extension can interrupt IV fluid delivery, introduce contamination risk, and potentially affect patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and patients relying on IV therapy may need to pause treatment and replace affected tubing, causing workflow disruption and potential costs.
Practical Guidance
How to identify if yours is affected
- 1. Locate model label on the device for 2C8610 and confirm 44-inch length.
- 2. Check for UDI/DI 00085412048963 or Lot number R25C31024.
- 3. Compare with recall list to confirm whether affected.
Where to find product info
Refer to the FDA recall page linked in Baxter recall notices and packaging labels.
What timeline to expect
4-6 weeks for refunds or replacements after recall submission.
If the manufacturer is unresponsive
- Escalate to hospital risk management or infection control.
- File a complaint with the FDA MEMS recall system if Baxter is unresponsive.
How to prevent similar issues
- Verify device IDs before use.
- Maintain recall checklists for IV equipment.
- Purchase from authorized suppliers and confirm recall status on delivery.
Documentation advice
Keep recall notice, capture photos of device labels, save purchase receipts and correspondence with Baxter.
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Product Details
Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 cm). Product code 2C8610. Brand: Baxter Healthcare. Model numbers: UDI/DI 00085412048963; Lot numbers: R25C31024. Quantity: 15,552. Distribution: US Nationwide distribution. Sold since: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: UDI/DI 00085412048963
- Lot: R25C31024
- 44-inch extension length
- Leakage risk in IV delivery
- FDA recall notice: Z-0197-2026
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Safety Guide
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