medical MODERATE Updated 2026-09-09

Fresenius Medical Care Renal Therapies Group, LLC recalls 5008X HD/HDF Standard Blood Tubing Set Part Number 03-

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Recalled Product

5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

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