Device recall

5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

FDA recall source

Recall number

Z-3084-2026

Event id

99556

Status

Ongoing

FDA classification

Class II

Recalling firm

Fresenius Medical Care Renal Therapies Group, LLC

Report date

Sep 9, 2026

Posted

Sep 2, 2026

Initiated

Aug 10, 2026

Center classification date

Sep 2, 2026

Product code

KOC

Device type

Accessories, Blood Circuit, Hemodialysis

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.

Root cause

Component change control

Quantity

120 units

Code info

Lots 25KR01227 25NR01257 UDI-DI 00840861102556

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.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K243505

Location

Waltham, MA, United States