Fresenius Medical Care Renal Therapies Group, LLC recalls CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
Reason for recall
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Lot / code information
- Model
- 03-2522-1
- UDI
- 00840861102402 (Bag), 10840861102409 (Case)
- Lot #
codes: 26AR01010, 26BR01072, 26CR01067, 26DR01160, 26DR01198, 26AR01011 — +148 moreShow all
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
What the firm 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.
DistributionShow detailsHide
Domestic: Nationwide Distribution;
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3225-2026
- FDA 510(k) clearance · K213992The device's official FDA premarket clearance record
- FDA device classification · FJKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5820The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Fresenius Medical Care Renal Therapies Group, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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