United StatesFresenius Medical Care is recalling the 5008X Standard HD Pre-Flush Standard Blood Tubing Set (Part No. 03-5110-6) and three 5008X HD/HDF tubing sets (Part Nos. 03-5300-3, 03-5300-3C, 03-5350-8) identified by the listed lot numbers and UDI-DIs. The recall was issued because of a heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment, which may lead to blood loss and hypovolemia.
What's being recalled
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States.
How to identify it
Lots 25KR01227 25NR01257 UDI-DI 00840861102556 Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518 Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532 Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)