CSMS #48463000 - FDA adds ethylene oxide sterilized medical devices processed at Steril Milano facilities in Monza and Reggiolo, Italy to Import Alert 89-04

U.S. Customs and Border Protection sent this bulletin at 06/10/2021 03:47 PM EDT

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CSMS #48463000 - FDA adds ethylene oxide sterilized medical devices processed at Steril Milano facilities in Monza and Reggiolo, Italy to Import Alert 89-04

The U.S. Food and Drug Administration (FDA) is aware of sterility issues with medical devices processed at the Steril Milano S.R.L. ethylene oxide (EtO) sterilization facilities, in Reggiolo and Monza, Italy that have resulted in multiple recalls. The FDA has been notified that Steril Milano falsified graphs and parameters of sterilization certificates for a variety of FDA-regulated medical products dating back to 2016. As the FDA works with multiple manufacturers, international partners, and U.S. federal partners to investigate the situation, we are advising the import community of the potential impact this may have on imported medical devices. The FDA believes 97 medical device firms may be affected. If your entry is held at the port of entry due to possibly being impacted by this situation, we ask that the following documentation be provided via ITACS to help expedite entry review:

Entry documents
Copies of product labeling
Sterility Certificates documenting contract sterilizers.

For live entries held at the port of entry, please submit your inquiry to the local FDA office by visiting FDA’s Import Offices and Ports of Entry webpage. For questions related to this event please contact: 2021DeviceSterilizationInquiries@fda.hhs.gov

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