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

Medical DevicesSource: FDA (device) · Date: 2026-09-09

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Fresenius Medical Care Renal Therapies Group, LLC
Product
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-08-10
Code info
Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
Product quantity
6,624 units
Voluntary mandated
Voluntary: Firm initiated
City
Waltham
State
MA
Country
United States
Event id
99556
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