Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Recall
- Recall Number
- Z-1736-2022
- Event Number
- 90763
- Firm
- Steris Corporation Hopkins Facility
- FEI Number
- 3000251274
- Product Code
- JOJ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 10, 2022
- Terminated
- October 30, 2024
- Address
- 6515 Hopkins Rd, Mentor, OH, 44060-4307
Description
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Product contains incorrect chemical indicators in packaging.
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: [email protected] or via fax to 440-392-8963 3) STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form.
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
619 boxes