5008X HD/HDF with CLiC Blood Tubing Set recall
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Why was 5008X HD/HDF with CLiC Blood Tubing Set recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532
- Product
- 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 18,600
- 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.
- Recall date
- September 9, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)