Reported Sep 9, 2026 · Ongoing · Updated Sep 16, 2026
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
- 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- Lot codes and dates
- LotsUDI-DI 00840861102518
25JR0180025KR0122425LR0100125NR0101825NR0127225PR0107725PR0121925PR01220
- Lots
- Amount recalled
- 62,544 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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