This article has been updated with a statement from Innovative Sterilization Technologies.
The FDA has issued a warning letter to Innovative Sterilization Technologies, claiming that the Dayton, Ohio-based company has been marketing its surgical device sterilization trays for non-cleared purposes.
Innovative Sterilization Technologies makes the One Tray reusable sealed sterilization container intended to hold reusable medical devices while they are flash-sterilized for immediate use. In its March 20, 2019, letter, released today, the agency said the company is marketing its product for two different intended uses outside of its original clearance — terminal sterile storage and terminal sterile storage with retained moisture.
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