FDA-Device2022-09-21Class III
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Steris Corporation Hopkins Facility
Hazard
Product contains incorrect chemical indicators in packaging.
Sold states
Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY
Affected count
619 boxes
Manufactured in
6515 Hopkins Rd, Mentor, OH, United States
Products
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1736-2022Don't want to check this manually?
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