Fresenius Medical Care Renal Therapies Group, Llc: Accessories, Blood Circuit, Hemodialysis
Recall Summary Fresenius Medical Care is recalling certain blood tubing sets (model 5008X HD/HDF, part number 03-5300-3) used in hemodialysis treatment because the connection between the arterial clip and tubing may leak during use. A leak during treatment could cause blood loss. The tubing sets were distributed nationwide in the U.S. and in Lithuania.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- 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/1ca4e850-e9c2-481f-bcad-f33e09f7a370