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Recall

Class II — Fresenius Medical Care Renal Therapies Group, LLC

Recalling firmFresenius Medical Care Renal Therapies Group, LLC
Registered facilityView this company's 11 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonCommunication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
ProductCombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Quantity1743026 units
DistributionDomestic: Nationwide Distribution;
Initiated2026-07-29
Classified2026-09-18
Recall numberZ-3225-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Fresenius Medical Care Renal Therapies Group, LLC (Z-3225-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99700/

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