5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Why it was recalled
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 to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected products and identifiers
Lots 25KR01227 25NR01257 UDI-DI 00840861102556 — 120 units
Record details
Fresenius Medical Care Renal Therapies Group, LLC — 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.