Recall Z-3225-2026— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-3225-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-29

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2026-07-29. It names one FDA 510(k) clearance: K213992. Product: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;. Reason: Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed..

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-07-29
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K213992 — CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC·cleared 2023-05-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.