Z-3225-2026Class II

CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number...

Name: Z-3225-2026 CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number...
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2026-07-29
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2026-07-29 / Open, Classified

FDA source

Recall record

Recall number: Z-3225-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-29
Posted: 2026-09-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
FDA root cause: Use error
Action: 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.
Quantity in commerce: 1743026 units
Distribution: Domestic: Nationwide Distribution;
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3225-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3225-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code FJK

K213992Class IICombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC / cleared 2023-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)