FDA Device recall Z-3225-2026
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors by Fresenius Medical Care Renal Therapies Group, citing communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3225-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-29 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
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.
Identifiers
| code_info | Model Number: 03-2522-1; UDI-DI: 00840861102402 (Bag), 10840861102409 (Case); Lot codes: 26AR01010, 26BR01072, 26CR010…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, 26CR0108 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Fresenius Medical Care Renal Therapies Group
- 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
All Fresenius Medical Care Renal Therapies Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3225-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.