Resource Optimization & Innovation LLC recalls regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indi…

Recall date

June 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2699-2020

FDA classification

Class II

Brand / firm

Resource Optimization & Innovation LLC

Sold / distributed

US Nationwide distribution including in the states of MO, NC, AR, OK.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.