Z-1166-2014Class II

VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600...

Name: Z-1166-2014 VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600...
Creator: Steris Corporation
Published: 2013-12-19
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-12-19 / Terminated / root cause: labeling and UDI

FDA source

Steris Corporation began a recall of 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... on 2013-12-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1166-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Posted: 2014-03-10
Terminated: 2014-03-26
Recalling firm: STERIS Corporation
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 270F using typical healthcare dynamic air removal steam sterilization cycles.
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Model LCC019, Lot #: 024552A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1166-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1166-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10

Product code JOJ

K103053Class IIVerify 270Fp Challenge PackSTERIS Corporation / cleared 2011-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)