—#182125

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.

FDA product code: JOJ — Indicator, Physical/Chemical Sterilization Process
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K982188
Affected lot / code info: Lot 719

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Resource Optimization & Innovation LLC
Address: 645 Maryville Centre Dr, Ste 200, Saint Louis, Missouri 63141-5846

Distribution

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

Timeline

Recall initiated: 2020-06-17
Terminated: 2022-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182125. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.