Fresenius Medical Care Renal Therapies Group, Llc: Dialysate Concentrate For Hemodialysis (liquid Or Powder)
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
- Reason
- Complaints of blue-green discoloration in product
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-14
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the country of Mexico.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b29366c6-d76a-4d65-bdad-5920d69cd893