regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage...
FDA Device Recall #Z-2699-2020 — Class II — June 17, 2020
Recall Summary
| Recall Number | Z-2699-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 17, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Resource Optimization & Innovation LLC |
| Location | Saint Louis, MO |
| Product Type | Devices |
| Quantity | 66 cases of 12,000 units per case |
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.
Distribution Pattern
US Nationwide distribution including in the states of MO, NC, AR, OK.
Lot / Code Information
Lot 719
Other Recalls from Resource Optimization & Innovation LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0950-2022 | Class II | Regard IV Start Kit for preparing and/or dressi... | Feb 28, 2022 |
| Z-2368-2020 | Class II | Regard SRHS GIC Port A Cath, Sterile, Qty 20/ca... | May 4, 2020 |
| Z-2369-2020 | Class II | Regard SRHS Central Line Kit, Sterile, 20/case ... | May 4, 2020 |
| Z-0169-2018 | Class II | Regard Custom Surgical Pack Packs contain su... | Sep 25, 2017 |
| Z-1654-2017 | Class II | Regard, Item Number: 800415003, Sterile, OR0484... | Jan 9, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.