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Moderate riskFDA DeviceClass II

Fresenius 5008X Standard HD blood tubing set recalled for blood leak risk

Fresenius Medical Care is recalling certain 5008X Standard HD Pre-Flush blood tubing sets due to a heightened risk of blood leaking from the connection between the Arterial Alpha Clip and the main line. A leak during dialysis treatment could result in blood loss.

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

What to do

  1. Check your tubing set lot number (25KR01227 or 25NR01257) against your records or contact your dialysis center.
  2. If you have an affected set, do not use it and notify your healthcare provider or dialysis facility immediately.
  3. Your dialysis center will provide a replacement tubing set.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Sold in
Nationwide
Made for
Adults

This recall covers 4 products — see all of them.

Details

Units affected
120 units
Illnesses reported
None reported
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Classification
Class II
Recall number
Z-3084-2026

In the FDA's words

Description
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 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 25KR01227 25NR01257 UDI-DI 00840861102556 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: 120 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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