Verify SixCess Challenge Pack. Used to confirm that… recallZ-1736-2022 · Steris Corporation Hopkins Facility · initiated Aug 10, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation Hopkins Facility or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product contains incorrect chemical indicators in packaging.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1736-2022
- Status
- Terminated
- Initiated by the company
- Aug 10, 2022
- Recalling firm
- Steris Corporation Hopkins Facility
- Quantity
- 619 boxes
- Product code
- JOJ
- FDA submissions
- K162758
- 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
Product description
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VERIFY SixCess LCC003Steris Corporation · Indicator, physical/chemical sterilization process1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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