Reported Sep 21, 2022 · Terminated

Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within…

Steris Corporation Hopkins Facility

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Steris Corporation Hopkins Facility · 6515 Hopkins Rd · Mentor, OH · 44060-4307

Is this the product you have?

  • Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Lot codes and dates
  • UDI-DI (GTIN)10724995088955
  • Item Number
    • LCC003
    • Lot 3411228A
Amount recalled
619 boxes

Where it was sold

Why it was recalled

Product contains incorrect chemical indicators in packaging.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 30, 2024 · Data as of Sep 19, 7:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.