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Open, Classified

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

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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