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Italian Sterilization Firm Falsified Certificates Since 2016; 97 Device Makers May Be Impacted, FDA Warns

Executive Summary

Biopsy needles, catheters, intravascular administration sets, arthroscopes and syringes are just a few of the products affected by the deception, some of which have already been recalled. The Steril Milano S.R.L. Reggiolo and Monza ethylene oxide sterilization facilities were shuttered in March.

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