Z-3092-2026 Class II Ongoing
FDA device recall Z-3092-2026 was initiated by Fresenius Medical Care Renal Therapies Group, LLC on July 14, 2026 and is designated Class II. Reason for recall: Complaints of blue-green discoloration in product The recall status is ongoing. Affected quantity: 2,998 cs; 68 ea.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- July 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,998 cs; 68 ea
Product Description
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
Reason for Recall
Complaints of blue-green discoloration in product
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Mexico.
Code Information
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.