FDA recall Z-2699-2020

Resource Optimization & Innovation LLC · Class II · device

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.

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-06-17
Report date
2020-08-05
Termination date
2022-07-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2699-2020