Health Canada — Medical Devices · Canada · 2021-07-13 · Type I
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Reported risk: Steril Milano is a contract sterilizer for Ethylene Oxide sterilization of Sidam. The quality issue detected by Steril Milano, during an internal audit, is due to the falsification of the cycle graphs and the manual editing of the treatment certificates in order to make them match with the new graphs associated to the cycles.
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