PlainRecalls
FDA Devices Low Class III Terminated

Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.

Reported: September 21, 2022 Initiated: August 10, 2022 #Z-1736-2022

Product Description

Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.

Reason for Recall

Product contains incorrect chemical indicators in packaging.

Details

Units Affected
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
Location
Mentor, OH

Frequently Asked Questions

What product was recalled?
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.. Recalled by Steris Corporation Hopkins Facility. Units affected: 619 boxes.
Why was this product recalled?
Product contains incorrect chemical indicators in packaging.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 21, 2022. Severity: Low. Recall number: Z-1736-2022.