Class IIDeviceOngoing

Fresenius Medical Care Renal Therapies Group, LLC

Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis

Reason for recall

Complaints of blue-green discoloration in product

Details

Recall number: Z-3093-2026
Event ID: 99543
Recall initiated: Jul 14, 2026
Classified: Sep 3, 2026
Reported: Sep 9, 2026
Quantity: 56,036 cs; 1,788 drums; 204 ea
Distribution: Worldwide distribution - US Nationwide and the country of Mexico.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Waltham, MA, United States
Lot / code info: 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.