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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 Device Recall VERIFY SixCess 270FP Challenge Packsee related information
Date Initiated by FirmDecember 19, 2013
Date PostedMarch 10, 2014
Recall Status1 Terminated 3 on March 26, 2014
Recall NumberZ-1166-2014
Recall Event ID 67308
510(K)NumberK103053 
Product Classification Indicator, physical/chemical sterilization process - Product Code JOJ
ProductVERIFY 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 270F using typical healthcare dynamic air removal steam sterilization cycles.
Code Information Model LCC019, Lot #: 024552A
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactMs. 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		Labeling False and Misleading
ActionThe 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 Commerce94 boxes/20 units
DistributionWorldwide 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JOJ
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