Fresenius Medical Care Renal Therapies Group, LLC: 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

Is my product affected?

5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

• UPC 00840861102518

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: 62,544 units Lot/code info: Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518

Source

Official record: FDA (Device enforcement) ↗

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

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