Recall Z-1736-2022 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Steris Corporation Hopkins Facility
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
| Date | Aug 10, 2022 |
| Status | Terminated |
| Reason | Product contains incorrect chemical indicators in packaging. |
| Root cause | Process control |
| Action | The recalling firm issued customer and distributor letters beginning 08/10/2022 to impacted consignees. Consignees are instructed to: 1) Immediately destroy on-hand inventory of LCC003 Challenge Packs, Lot 3411228A 2) Complete the Medical Device Recall Response Form included with the notification letter and return the complete form via email to: Regulatory_Compliance@steris.com or via fax to 440-392-8963 3) STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. |
| Quantity | 619 boxes |
| Distribution | Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge STERIS Corporation, Mar 21, 2017 |