FDA recall Z-1736-2022

Product

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.

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

Key facts

Status

Terminated

Initiation date

2022-08-10

Report date

2022-09-21

Termination date

2024-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1736-2022