FDA-Device2014-03-19Class II

VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.

Steris Corporation
Hazard

STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.

Sold states
Worldwide Distribution: US (nationwide) including states of: IL, LA, ME, MI, NC, OH, OK, VA, WI & WV; and to the country of: Canada. Product was also shipped to Canada.
Affected count
94 boxes/20 units
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1166-2014

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