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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description 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.
Recall Number Z-1166-2014
Classification Class II
Code Info Model LCC019, Lot #: 024552A
Product Distributed Qty 94 boxes/20 units
Reason For Recall 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.

Event Detail

Event Id 67308
Product Type Devices
Status Ongoing
Recalling Firm Steris Corporation
City Mentor
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-19
Initial Firm Notification of Consignee or Public Letter
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.