Fresenius Medical Care Renal Therapies Group, Llc: Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
- Reason
- Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d5cc6fa3-ff3f-4327-a35c-2f833cb88e0d