--- title: "5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the followin... — FDA record Z-1992-2025 | Is It on Recall" description: "Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltratio" url: https://isitonrecall.com/recall/fda-device-z-1992-2025-5008x-hdf-hemodialysis-blood-tubing-set-24-units-per-case-with-the-following-models-a-5008x-standard/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodlin... — FDA record Z-1992-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Apr 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2. - **Reason**: Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration. - **Classification**: Class II - **Recalling firm**: Fresenius Medical Care Holdings, Inc. - **Quantity**: Model Number, Cases (Eaches): 03-5100-7, 76 (1,824); 03-5100-7C, 5 (120); 03-5150-2, 8 (192) - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1992-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1992-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | a. Model Number: 03-5100-7; UDI-DI: 00840861102365 (Bag), 10840861102362 (Case); Lot Numbers: 24LR01214, 24SR01010, 25ER01800. b. Model Number: 03-5100-7C; UDI-DI: 0084086110237 (Bag), 10840861102379 (Case); Lot Number: 24LR01215, 24SR01011, 25ER01804. c. Model Number: 03-5150-2; UDI-DI: 00840861102389 (Bag), 10840861102386 (Case); Lot Number: 24LR01216, 24SR01012, 25ER01805. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide distribution in the state of Massachusetts. States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1992-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Fresenius Medical Care Holdings, Inc. records](https://isitonrecall.com/brand/fresenius-medical-care-holdings-inc/)