Fresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review
Fresenius Medical Care is recalling CombiSet Hemodialysis Blood Tubing Sets to ensure treatment preparation and handling steps are performed as instructed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a precautionary recommendation to review handling instructions without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 1,743,026 units of CombiSet Hemodialysis Blood Tubing Sets with Attached Priming Set and Transducer Protectors, Model Number 03-2522-1. The product was distributed nationwide in the United States.
The recall was initiated to recommend reviewing the Instructions for Use (IFU) and ensuring that all treatment preparation and handling steps are performed as instructed. The source text does not specify a particular defect, injury, or illness associated with the product.
Healthcare providers and facilities should review the IFU and verify that all preparation and handling procedures are being followed correctly. Consumers should not use the product if they have questions about its proper handling.
The recalled product
- Product
- CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
- Hazard
- Affected units
- 1,743,026
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: 03-2522-1
- UDI-DI: 00840861102402 (Bag)
- 10840861102409 (Case)
- Lot codes: 26AR01010
- 26BR01072
- 26CR01067
- 26DR01160
- 26DR01198
- 26AR01011
- 26BR01074
- 26CR01069
- 26DR01161
- 26DR01203
- 26AR01034
- 26BR01076
- 26CR01070
- 26DR01162
- 26DR01206
- 26AR01035
- 26BR01077
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC
See all →- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X Blood Tubing Set Recalled for Potential Blood Leak
FDA (Devices) · 2026-09-09
- HighFresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration
FDA (Devices) · 2026-09-09
- SevereFresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
Same hazard · improper handling
See all →- HighGE Healthcare nuclear medicine imaging systems recalled for detector mounting risk
FDA (Devices) · 2025-01-22
- Moderate