Recalls / —
—#125270
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.
- FDA product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K103053
- Affected lot / code info
- Model LCC019, Lot #: 024552A
Why it was recalled
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 (FDA determination)
Labeling False and Misleading
Action the firm took
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.
Recalling firm
- Firm
- Steris Corporation
- Address
- 5960 Heisley Rd, Mentor, Ohio 44060-1834
Distribution
- 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.
Timeline
- Recall initiated
- 2013-12-19
- Posted by FDA
- 2014-03-10
- Terminated
- 2014-03-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #125270. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.