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Moderate riskFDA DeviceClass II

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

Fresenius Medical Care is recalling certain 5008X HD/HDF blood tubing sets (part number 03-5300-3C) due to a heightened risk of blood leaks at the connection between the Arterial Alpha Clip and the main line. Blood leaks during dialysis treatment can result in significant blood loss.

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

What to do

  1. Check if your dialysis clinic uses the affected tubing sets (part number 03-5300-3C, lots 25JR01801, 25KR01225, 25KR01251, 25NR01016, or 25NR01265).
  2. Contact your dialysis provider or Fresenius immediately if you have questions about your tubing sets.
  3. Do not use affected tubing sets; follow your clinic's instructions for replacement or corrective action.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Sold in
Nationwide
Made for
Adults

This recall covers 4 products — see all of them.

Details

Units affected
18,600
Illnesses reported
None reported
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Classification
Class II
Recall number
Z-3086-2026

In the FDA's words

Description
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C 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 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532 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: 18,600
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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