Reported Jun 25, 2025 · Ongoing
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models
Fresenius Medical Care Holdings, Inc.
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 Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models
3 of 3 products
| Model / number | Product as published |
|---|---|
03-5100-7. | 5008X Standard HDF Bloodline |
03-5100-7C. | 5008X Standard HDF Bloodline w/CLIC |
03-5150-2. | 5008X Standard HDF Bloodline w/ Twister |
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 03-5100-70084086110236510840861102362UDI-DI: 00840861102365 (Bag), 10840861102362 (Case); Lot Numbers: 24LR01214, 24SR01010, 25ER01800. 03-5100-7C008408611023710840861102379UDI-DI: 0084086110237 (Bag), 10840861102379 (Case); Lot Number: 24LR01215, 24SR01011, 25ER01804. 03-5150-20084086110238910840861102386UDI-DI: 00840861102389 (Bag), 10840861102386 (Case); Lot Number: 24LR01216, 24SR01012, 25ER01805. - Amount recalled
- Model Number, Cases (Eaches): 03-5100-7, 76 (1,824); 03-5100-7C, 5 (120); 03-5150-2, 8 (192)
Where it was sold
- Nationwide
- MA
Why it was recalled
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
This product could cause temporary or reversible health problems — stop using it.
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