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Class IIOngoing

Fresenius Medical Care Renal Therapies Group, LLC recalls CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors

Recall date · record updated Sep 30, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Fresenius Medical Care Renal Therapies Group, LLC
Reason
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Domestic: Nationwide Distribution;
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99700…

Products

  1. CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;

    Codes/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, 26BR0Quantity: 1743026 unitsRecall no. Z-3225-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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