The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Reason for recall: The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. Distribution: US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL. Quantity: 1950 units Lot/code info: UDI/DI 40889942539858 (case), 10889942539857 (each), Lot numbers: 2023032090, 2023020990, 2022103190, 2022091690, 2022070190, 2022052090, 2022042290, 2022033190, 2021102290, 2021092190
40889942539858, 10889942539857
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.