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Moderate riskFDA DeviceClass II

Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk

Fresenius Medical Care is recalling certain 5008X HD/HDF Standard Blood Tubing Sets due to a heightened risk of blood leaking from the connection between the Arterial Alpha Clip and the main line or pump segment. A blood leak during dialysis treatment could result in blood loss and low blood volume.

From the FDA notice · Read the official notice ↗ · All Fresenius Medical Care recalls

What to do

  1. Check if your dialysis center uses the affected tubing (part number 03-5300-3, lots 25JR01800, 25KR01224, 25LR01001, 25NR01018, 25NR01272, 25PR01077, 25PR01219, or 25PR01220).
  2. Contact your dialysis provider or Fresenius for instructions on replacement or safe use of remaining stock.
  3. Report any blood leaks or injuries to Fresenius and the FDA.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Sold in
Nationwide
Made for
Adults

This recall covers 4 products — see all of them.

Details

Units affected
62,544 units
Illnesses reported
None reported
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Classification
Class II
Recall number
Z-3085-2026

In the FDA's words

Description
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 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. Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518 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. Affected quantity: 62,544 units
Hazard
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.

4 products in this recall

Fresenius 5008X blood tubing sets recalled for blood leak risk

Fresenius Medical Care is recalling four 5008X blood tubing set models because the connection between the Arterial Alpha Clip and the main line or pump segment may leak blood during treatment. A leak could cause blood loss and low blood volume. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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