Fresenius Medical Care Renal Therapies Group, Llc: Accessories, Blood Circuit, Hemodialysis
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1a2c9a9b-80f8-4a68-9ceb-f68bd5608920