5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 recall (Fresenius Medical Care Renal Therapies Group, LLC)

Medical deviceClass IIOngoing

Summary: Fresenius Medical Care Renal Therapies Group, LLC is recalling 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8. Reason: 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.

What is being recalled

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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. (states named: Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia)

How to tell if yours is affected

Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Fresenius Medical Care Renal Therapies Group, LLC · all medical device recalls · recalls from August 2026

Official FDA record