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U.S. Department of Health and Human Services

Class 3 Device Recall Verify

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 Class 3 Device Recall Verifysee related information
Date Initiated by FirmAugust 10, 2022
Create DateSeptember 10, 2022
Recall Status1 Terminated 3 on October 30, 2024
Recall NumberZ-1736-2022
Recall Event ID 90763
510(K)NumberK162758 
Product Classification Indicator, physical/chemical sterilization process - Product Code JOJ
ProductVerify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Code Information UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Recalling Firm/
Manufacturer		 Steris Corporation Hopkins Facility
6515 Hopkins Rd
Mentor OH 44060-4307
For Additional Information ContactTammy Gentry
440-392-8625
Manufacturer Reason
for Recall		Product contains incorrect chemical indicators in packaging.
FDA Determined
Cause 2		Process control
ActionThe 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: Regulatory_Compliance@steris.com 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 Commerce619 boxes
DistributionDistribution 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JOJ
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