Fresenius Medical Care Renal Therapies Group, LLC: 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C

Is my product affected?

5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C

• UPC 00840861102532

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: 18,600 Lot/code info: Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532

Source

Official record: FDA (Device enforcement) ↗

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

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