Official recall notice
FDA Recall: NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2
- Recall date
- 2026-09-09
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Complaints of blue-green discoloration in product
Product description
Complaints of blue-green discoloration in product
Affected products
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.