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.
Recall
- Recall Number
- Z-2699-2020
- Event Number
- 85907
- Firm
- Resource Optimization & Innovation LLC
- FEI Number
- 3004513970
- Product Code
- JOJ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- June 17, 2020
- Terminated
- July 29, 2022
- Address
- 645 Maryville Centre Dr, Ste 200, Saint Louis, MO, 63141-5846
Description
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.
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.
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.
US Nationwide distribution including in the states of MO, NC, AR, OK.
66 cases of 12,000 units per case