The actual product was not returned and there were neither product code, description or product lot number provided, the complaint could not be fully investigated.Several attempts were made to collect additional details without any success.The mesh product is provided sterile to the user.The product is sterilized using a traditional 3-step ethylene oxide (eo) cycle that delivers a 10-6 sterility assurance level (sal).This cycle is validated using biological indicators (bis) per the ¿overkill method¿ outlined in ansi/aami/iso 11135-1:2007, sterilization of health care products.Related mdrs: 1219977-2014-00405 and 00406.
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