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Recall Observatory FDA recall evidence

Device product

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

Z-1736-2022

August 10, 2022

Class III

Product summary

Firm
Steris Corporation Hopkins Facility
Event
Event 90763
Status
Terminated
Classification
Class III
Quantity
619 boxes
Official record key
device-enforcement:Z-1736-2022

Official wording

Reason: Product contains incorrect chemical indicators in packaging.

Code information: UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product contains incorrect chemical indicators in packaging.