Potentially compromised sterile barrier. The conformity of the products was questioned by the German health authority due to packaging tests not adequately performed. Single sterilized and transport conditioned according to ASTM d4169-22 was conducted. However, the test samples were not double sterilized to cover an assumed worst condition of sterilization impact. These required tests are currently under way, however these test results will not be available until earliest in April 2023. Recall start date: January 9, 2023
RecallTracker