Baxter Healthcare Corporation: DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b)

Hazard

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Details from the source

Reason for recall: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Distribution: Nationwide in the USA Quantity: a) 44,520; b) 60,762; c) 483,912 Lot/code info: a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. b) Lot 408790, Exp 30-Nov-2024 and c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025

Source

Official record: FDA (Drug enforcement) ↗

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