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FDA (Device enforcement)Recalled 2026-08-10class ii

Fresenius Medical Care Renal Therapies Group, LLC: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

Is my product affected?

5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

  • UPC 00840861102556

Check against the official notice below — it lists the full affected range.

Hazard

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

Details from the source

Reason for recall: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania. Quantity: 120 units Lot/code info: Lots 25KR01227 25NR01257 UDI-DI 00840861102556

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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