FDA-Device2020-08-05Class II
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.
Resource Optimization & Innovation LLC
Hazard
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.
Sold states
US Nationwide distribution including in the states of MO, NC, AR, OK.
Affected count
66 cases of 12,000 units per case
Manufactured in
645 Maryville Centre Dr Ste 200, N/A, Saint Louis, MO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2699-2020Don't want to check this manually?
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