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Moderate riskFDA DeviceClass II

Fresenius 5008X HD/HDF Twister Blood Tubing Set recalled for blood leak risk

Fresenius Medical Care is recalling specific lots of the 5008X HD/HDF Twister Blood Tubing Set (Part Number 03-5350-8) because the connection between the Arterial Alpha Clip and the main line may leak during dialysis treatment. A leak 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 your dialysis tubing set for the affected lot numbers: 25JR01802, 25NR01017, or 25NR01266.
  2. Contact your dialysis center or Fresenius immediately if you have one of these lots.
  3. Do not use the affected tubing set.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Sold in
Nationwide
Made for
Adults

This recall covers 4 products — see all of them.

Details

Units affected
6,624 units
Illnesses reported
None reported
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Classification
Class II
Recall number
Z-3087-2026

In the FDA's words

Description
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 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 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525 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: 6,624 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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