Device recall
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
- Recall number
- Z-3093-2026
- Event id
- 99543
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Report date
- Sep 9, 2026
- Posted
- Sep 3, 2026
- Initiated
- Jul 14, 2026
- Center classification date
- Sep 3, 2026
- Product code
- KPO
- Device type
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Reason
- Complaints of blue-green discoloration in product
- Root cause
- Material/Component Contamination
- Quantity
- 56,036 cs; 1,788 drums; 204 ea
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the country of Mexico.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States