CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
FDA Recall Z-3225-2026 · Posted 2026-09-18
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Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusOpen, Classified
Product CodeFJK
Date Initiated2026-07-29
Product Quantity1743026 units
Reason for Recall
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Firm Action
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.
Root Cause
Use error
Distribution Pattern
Domestic: Nationwide Distribution;
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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