Quick Facts at a Glance
- Recall Date
- August 29, 2025
- Hazard Level
- HIGH
- Brand
- Baxter
- 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
- Product type
- IV infusion set
- Model numbers
- UDI/DI 00085412565774, Lot R25A13024, Product Code 2R8858
- Sizes
- 107-inch tubing
- 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
The CLEARLINK Paclitaxel IV Set is used to administer chemotherapy via IV. It features non-vented tubing and a CLEARLINK Luer Activated Valve with a 0.2 micron filter and 107-inch tubing.
Why This Is Dangerous
Leaks at the infusion set can cause unintended leakage and improper drug delivery, potentially exposing healthcare workers and patients to chemotherapy agents.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to quarantine affected lots and switch to approved devices. No patient injuries are cited in the notice.
Practical Guidance
How to identify if yours is affected
- Verify product code 2R8858 on the device label
- Check UDI/DI 00085412565774
- Confirm lot number R25A13024
- Ensure tubing length is 107 inches and features 0.2 micron filter with non-vented design
Where to find product info
Product labels, package inserts, and recall notice. The recall page provides official identifiers.
What timeline to expect
No public timeline is provided. Hospitals should follow Baxter instructions and monitor for updates.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a report with Baxter recall team
- If needed, contact FDA recall hotlines or regional authorities for assistance
How to prevent similar issues
- In future purchases, verify device identifiers before stocking
- Maintain a current list of approved vendors and recall statuses
- Institute standard testing for leak-prone infusion sets before deployment
Documentation advice
Keep a copy of the recall notice, store device identifiers, document all correspondence with Baxter and distributors, and record replacement status
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Product Details
Product: CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, 10 drops/mL, 107-inch (2.7 m) tubing. Product Code 2R8858. UDI/DI 00085412565774. Lot numbers: R25A13024. Quantity: 27,072 units. Sold nationwide in the US via healthcare distributors.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code 2R8858
- Lot R25A13024
- 107-inch tubing length
- Non-vented with polyethylene-lined tubing
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Safety Guide
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