FDA-Device2026-09-30Class IIMISBRANDING
Fresenius CombiSet hemodialysis blood tubing set needs proper preparation review
What this means
Fresenius Medical Care is issuing a communication regarding its CombiSet hemodialysis blood tubing set (Model 03-2522-1) to ensure healthcare providers and patients review the product's instructions for use. The company is recommending that all treatment preparation and handling steps be performed exactly as instructed to maintain safe operation.
- If you use or administer this hemodialysis tubing set, review the instructions for use (IFU) carefully
- Ensure all treatment preparation and handling steps are performed exactly as written in the instructions
- Contact Fresenius Medical Care if you have questions about proper use
The agency's original wording
Hazard
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Intended for
Adults
Illnesses reported
None reported
Sold states
Domestic: Nationwide Distribution;
Affected count
1743026 units
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3225-2026More Fresenius Medical Care recalls
- FDA-Device2026-09-09Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk during dialysis
- FDA-Device2026-09-09Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk
- FDA-Device2026-09-09Fresenius Citrasate Liquid Acid Concentrate recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius NaturaLyte Liquid Acid Concentrate for Hemodialysis recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius GRANUFLO Dry Acid Concentrate recalled for blue-green discoloration
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