Fresenius Medical Care Renal Therapies Group, LLC: 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,

Is my product affected?

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

• UPC 00840861101658
• UPC 00840861101696
• UPC 00840861101702
• UPC 00840861101740
• UPC 00840861101757
• UPC 00840861101849
• UPC 00840861101863
• UPC 00840861101887

Check against the official notice below — it lists the full affected range.

Hazard

Complaints of blue-green discoloration in product

Details from the source

Reason for recall: Complaints of blue-green discoloration in product Distribution: Worldwide distribution - US Nationwide and the country of Mexico. Quantity: 2,998 cs; 68 ea Lot/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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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