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: 1800 units Lot/code info: UDI/DI 40889942651062 (case), 10889942651061 (each), Lot numbers: 2023042190, 2022101090, 2022081590, 2022041390, 2022031090, 2022011290, 2021100490
40889942651062, 10889942651061
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.