Regard, T AND A - Rogers, sterilized convenience kits
FDA Device Recall #Z-0469-2022 — Class II — November 30, 2021
Recall Summary
| Recall Number | Z-0469-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 30, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ROi CPS LLC |
| Location | Republic, MO |
| Product Type | Devices |
| Quantity | 195 kits |
Product Description
Regard, T AND A - Rogers, sterilized convenience kits
Reason for Recall
Kits lacks rubber latex warning label.
Distribution Pattern
US Nationwide distribution in the state of MO.
Lot / Code Information
1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023
Other Recalls from ROi CPS LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1047-2025 | Class I | regard Item Number: 830106006, LD01114F - Newbo... | Dec 26, 2024 |
| Z-3159-2024 | Class II | regard Clinical Packaging Solutions, HT00376I -... | Jul 24, 2024 |
| Z-2685-2024 | Class II | Regard Kit containing the Microtek decanter | Jun 17, 2024 |
| Z-0620-2024 | Class I | regard Operative LAP, Item Number 800943001; su... | Dec 18, 2023 |
| Z-0596-2024 | Class I | Regard Dressing change kit, Item Number 800026006 | Nov 20, 2023 |
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.