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U.S. Department of Health and Human Services

Class 2 Device Recall regard Migrating Indicator

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  Class 2 Device Recall regard Migrating Indicator see related information
Date Initiated by Firm June 17, 2020
Create Date July 24, 2020
Recall Status1 Terminated 3 on July 29, 2022
Recall Number Z-2699-2020
Recall Event ID 85907
510(K)Number K982188  
Product Classification Indicator, physical/chemical sterilization process - Product Code JOJ
Product regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
Code Information Lot 719
Recalling Firm/
Manufacturer		 Resource Optimization & Innovation LLC
645 Maryville Centre Dr Ste 200
Saint Louis MO 63141-5846
Manufacturer Reason
for Recall		 The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by email on 06/17/2020. The letter requested the customer quarantine any product and notify the firm. ROi, LLC will facility the return of the product. The letter also directed the customer notify all potential users how may have received the recalled item.
Quantity in Commerce 66 cases of 12,000 units per case
Distribution US Nationwide distribution including in the states of MO, NC, AR, OK.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JOJ and Original Applicant = STERITEC PRODUCTS MFG. CO., INC.
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