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
Product summary
- 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
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.