A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Reason for recall: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection. Distribution: US: TX, IL, CA Quantity: 105 units Lot/code info: UDI/DI Case 40195327231126, UDI/DI Each 10195327231125; Lot Numbers: 22LBM357
40195327231126, 10195327231125
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.