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.
FDA Recall Z-2699-2020 · Posted None
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Recalling FirmResource Optimization & Innovation LLC
Recall StatusTerminated
Product CodeJOJ
Date Initiated2020-06-17
Date Terminated2022-07-29
Product Quantity66 cases of 12,000 units per case
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including in the states of MO, NC, AR, OK.
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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