Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
FDA Recall Z-1736-2022 · Posted None
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Recalling FirmSteris Corporation Hopkins Facility
Recall StatusTerminated
Product CodeJOJ
Date Initiated2022-08-10
Date Terminated2024-10-30
Product Quantity619 boxes
Reason for Recall
Product contains incorrect chemical indicators in packaging.
Firm Action
The recalling firm issued customer and distributor letters beginning 08/10/2022 to impacted consignees. Consignees are instructed to:
1) Immediately destroy on-hand inventory of LCC003 Challenge Packs, Lot 3411228A
2) Complete the Medical Device Recall Response Form included with the notification letter and return the complete form via email to: [email protected] or via fax to 440-392-8963
3) STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form.
Root Cause
Process control
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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