5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Summary
The FDA issued a Class II for 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C by Fresenius Medical Care Renal Therapies Group, LLC. 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 .
Details
Source
Device Recall
External ID
Z-3086-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Lot/Code Info: Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532
Quantity Affected: 18,600
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-10
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Fresenius Medical Care Renal Therapies Group, LLC has 33 FDA actions in our database, including 9 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Medical Care Renal Therapies Group, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Medical Care Renal Therapies Group, LLC have FDA actions?
Fresenius Medical Care Renal Therapies Group, LLC has 33 FDA actions in our database, including 9 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3086-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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