Fresenius Medical Care Renal Therapies Group, LLC recalls 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.
Read the official notice →- Date
- 2026-09-09
- Country
- United States
- Brand
- Fresenius Medical Care Renal Therapies Group
- Product
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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