Mentor, OH, United States
Steris Corporation Hopkins Facility recalls
1 recall recorded since 2018, most recently on 10 August 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 10 August 2022
- Terminated
- 30 October 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1736-2022
- Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.