Device recall
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
- Recall number
- Z-3092-2026
- 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
- 2,998 cs; 68 ea
- Code info
- 1) 08-1251-1, UDI/DI 00840861101658, Lot Numbers: 26AXAC056; 2) 08-2251-0, UDI/DI 00840861101696, Lot Numbers: 26AXAC050, 26BXAC012, 26BXAC042; 3) 08-2301-3, UDI/DI 00840861101702, Lot Numbers: 26BXAC013, 26BXAC045; 3) 08-3251-9, UDI/DI 00840861101740, Lot Numbers: 26AXAC051, 26BXAC011, 26BXAC043; 4) 08-3301-2, UDI/DI 00840861101757, Lot Numbers: 26AXAC052; 5) 13-2201-5, UDI/DI 00840861101849, Lot Numbers: 26AXAC062, 26AXAC064; 6) 13-2251-0, UDI/DI 00840861101863, Lot Numbers: 26AXAC041, 26AXAC058, 26AXAC059, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC034, 26BXAC049, 26BXAC051; 7) 13-3251-9, UDI/DI 00840861101887, Lot Numbers: 26BXAC037, 26BXAC048.
- Distribution
- Worldwide distribution - US Nationwide and the country of Mexico.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States