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U.S. Department of Health and Human Services

Class 2 Device Recall VERIFY SixCess 270FP Challenge Pack

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 Class 2 Recall
VERIFY SixCess 270FP Challenge Pack
see related information
Date Posted March 10, 2014
Recall Status1 Terminated on March 26, 2014
Recall Number Z-1166-2014
Recall Event ID 67308
Premarket Notification
510(K) Number
K103053 
Product Classification Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
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.
Code Information Model LCC019, Lot #: 024552A
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Ms. Kathryn E. Cadorette
440-392-7231
Manufacturer 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.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action The firm, Steris, sent an "URGENT VOLUNTARY RECALL NOTICE" dated December 20, 2013 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to verify if the outer packaging of your on-hand inventory contains lot number 024522A; destroy any remaining inventory of the affected product in your possession and contact STERIS Customer Service at 1-800-548-4873 to obtain no cost replacement product and if you do not have the affected product in your inventory, no further action is required. If you have any questions regarding this matter, please contact your STERIS Account Manager or STERIS Customer Service at 1-800-548-4873.
Quantity in Commerce 94 boxes/20 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JOJ and Original Applicant = STERIS CORPORATION
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