CombiSet recallZ-3225-2026 · Fresenius Medical Care Renal Therapies Group, LLC · initiated Jul 29, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Renal Therapies Group, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
FDA root cause category: Use error
What the company is doing
On July 30, 2026 IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers. Letter provides information and instructions on the use of the device. As part of routine best practice, we recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. There are potential risks to patient health that are associated with blood loss, treatment delay, or air entering the system. Ensure all steps of the IFU are followed, that the Transducer Protector connection to the bloodline monitor line is tight, and that the transducer protector and female luer connections are finger tight to maintain a closed system. Please contact FMCRTG Technical Service at 1-800-227-2572 if you have any further questions. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Recall details
- Recall number
- Z-3225-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 29, 2026
- Posted by the FDA
- Sep 18, 2026
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 1743026 units
- Product code
- FJK
- FDA submissions
- K213992
- Distribution
- Domestic: Nationwide Distribution;
Product description
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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, 26CR01072, 26DR01163, 26DR01207, 26AR01046, 26BR01078, 26CR01073, 26DR01165, 26DR01209, 26AR01047, 26BR01079, 26CR01074, 26DR01166, 26DR01210, 26AR01056, 26BR01082, 26CR01075, 26DR01167, 26DR01255, 26AR01057, 26BR01083, 26CR01076, 26DR01168, 26ER01022, 26AR01058, 26BR01084, 26CR01079, 26DR01170, 26ER01023, 26AR01059, 26BR01085, 26CR01080, 26DR01171, 26ER01024, 26AR01230, 26BR01087, 26CR01081, 26DR01172, 26ER01029, 26BR01007, 26BR01088, 26CR01082, 26DR01173, 26ER01034, 26BR01035, 26BR01210, 26CR01083, 26DR01174, 26ER01035, 26BR01036, 26CR01014, 26CR01084, 26DR01175, 26ER01037, 26BR01037, 26CR01045, 26CR01085, 26DR01177, 26ER01039, 26BR01039, 26CR01046, 26CR01086, 26DR01180, 26ER01040, 26BR01045, 26CR01047, 26CR01087, 26DR01182, 26ER01042, 26BR01049, 26CR01048, 26CR01088, 26DR01183, 26ER01044, 26BR01051, 26CR01049, 26CR01090, 26DR01184, 26ER01048, 26BR01052, 26CR01051, 26CR01091, 26DR01185, 26ER01049, 26BR01053, 26CR01052, 26CR01092, 26DR01186, 26ER01054, 26BR01057, 26CR01054, 26CR01093, 26DR01187, 26ER01055, 26BR01058, 26CR01056, 26CR01094, 26DR01188, 26ER01056, 26BR01059, 26CR01057, 26CR01206, 26DR01189, 26ER01062, 26BR01060, 26CR01058, 26CR01207, 26DR01190, 26ER01065, 26BR01063, 26CR01059, 26CR01208, 26DR01191, 26ER01066, 26BR01064, 26CR01060, 26CR01209, 26DR01193, 26ER01074, 26BR01065, 26CR01061, 26CR01210, 26DR01194, 26ER01266, 26BR01066, 26CR01064, 26DR01013, 26DR01195, 26ER01268, 26BR01067, 26CR01065, 26DR01158, 26DR01196, 26ER01282, 26BR01069, 26CR01066, 26DR01159, 26DR01197;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CombiSet 03-2522-1Fresenius Medical Care Holdings, Inc. · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve1 recall214 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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