MAQUET Cardiovascular LLC, 1124877, Acrobat-i and Acrobat SUV Stabilizer/Positioner

On 7 August 2024, the contract manufacturer (located in Suzhou, China) of the Acrobat product family (see product codes in above table) reported deviations in the manufacturing process that creates the sterile barrier. Specifically, in some instances, the tray sealing step was  performed multiple times using the same package, which is outside of the validated process. Although testing suggests that product is sterile immediately after being sealed with this non-validated process, we cannot ensure that the product will remain sterile for the duration of its 2-year shelf life. Therefore, MCV/Getinge has determined that this issue potentially impacts all manufactured lots of the affected products and is removing affected product within its shelf life from the field.