Z-1736-2022Class III

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

Name: Z-1736-2022 Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been...
Creator: Steris Corporation Hopkins Facility
Published: 2022-08-10
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2022-08-10 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation Hopkins Facility began a recall of Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design on 2022-08-10. FDA classified it as Class III and gives the reason as "Product contains incorrect chemical indicators in packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1736-2022
Classification: Class III
Status: Terminated
Initiated: 2022-08-10
Posted: 2022-09-10
Terminated: 2024-10-30
Recalling firm: STERIS Corporation
Product: Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: Product contains incorrect chemical indicators in packaging.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 619 boxes
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 codes and lots: UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1736-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1736-2022	Class III	Terminated	Voluntary: Firm initiated	2022-09-21	2022-09-09

Product code JOJ

K162758Class IIVERIFY 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)