Fresenius Medical Care Renal Therapies Group, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Complaints of blue-green discoloration in product
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
1) 08-2251-CA, UDI/DI 00840861101344, Lot Numbers: 26BXAC038; 2) 08-3251-CA, UDI/DI 00840861101351, Lot Numbers: 26BXAC039; 3) 13-2251-CA, UDI/DI 00840861101375, Lot Numbers: 26BXAC040, 26BXAC041.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →