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Recall Observatory FDA recall evidence

Device product

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.

Z-1166-2014

December 19, 2013

Class II

Product summary

Firm
Steris Corporation
Event
Event 67308
Status
Terminated
Classification
Class II
Quantity
94 boxes/20 units
Official record key
device-enforcement:Z-1166-2014

Official wording

Reason: 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.

Code information: Model LCC019, Lot #: 024552A

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.