Recall Z-1736-2022— Steris Corporation Hopkins Facility

Name: FDA recall Z-1736-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-10

Class III · Terminated

Class III FDA medical device recall by Steris Corporation Hopkins Facility, initiated 2022-08-10, terminated 2024-10-30. It names one FDA 510(k) clearance: K162758. Product: Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.. Reason: Product contains incorrect chemical indicators in packaging..

Recalling firm: Steris Corporation Hopkins Facility
Classification: Class III
Status: Terminated
Initiated: 2022-08-10
Terminated: 2024-10-30
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K162758 — VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge PackSTERIS Corporation·cleared 2017-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.