FDA recall Z-3087-2026

Fresenius Medical Care Renal Therapies Group, LLC · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2026-08-10
Report date: 2026-09-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3087-2026