5008X HD/HDF Standard Blood Tubing Set recall
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Why was 5008X HD/HDF Standard 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 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518
- Product
- 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 62,544 units
- 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)