FDA WARNING_LETTER - Steris Corporation

The FDA issued a Warning Letter to Steris Corporation regarding their Steris System 1 Processor (SS1) and Sterilant 20, a liquid chemical sterilizer. The FDA's review of documents revealed significant, uncleared changes to the device, rendering it adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Federal Food, Drug, and Cosmetic Act.

The SS1 was initially cleared via a 510(k) in 1989. However, subsequent modifications, which significantly affect safety or effectiveness, were made without new 510(k) submissions, as required by 21 CFR 807.81(a)(3). These changes include: 1. **Circulation Pump Change:** From a [redacted] pump to a [redacted] pump in 1999, altering flow rates and sterilant delivery. 2. **High Pressure Pump Change:** From a [redacted] pump to a [redacted] pump in 1992 (Model 90) and further replacements in 1999, impacting flow and sterilant delivery. 3. **Software Modification:** In 1996, software was changed to limit high-pressure pump operation, potentially affecting chemical residue removal. 4. **Quick Connect Kit Redesign:** In