Recall Z-2699-2020— Resource Optimization & Innovation LLC

Name: FDA recall Z-2699-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-17

Class II · Terminated

Class II FDA medical device recall by Resource Optimization & Innovation LLC, initiated 2020-06-17, terminated 2022-07-29. It names one FDA 510(k) clearance: K982188. 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: 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..

Recalling firm: Resource Optimization & Innovation LLC
Classification: Class II
Status: Terminated
Initiated: 2020-06-17
Terminated: 2022-07-29
Firm location: Saint Louis, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K982188 — STERI-PAK BOWIE DICK TEST PACKSteritec Products Mfg Co, Inc.·cleared 1998-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.