VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY S
FDA device recall Z-1166-2014 · posted 2014-03-10 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- JOJ
- Quantity affected
- 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.
- Date initiated
- 2013-12-19
- Date posted
- 2014-03-10
- Date terminated
- 2014-03-26
- Location
- Mentor, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERIFY 270FP CHALLENGE PACK (K103053) | STERIS Corporation | 2011-03-10 |