Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Ite...

FDA Device Recall #Z-1004-2022 — Class II — March 18, 2022

Recall Summary

Recall Number Z-1004-2022
Classification Class II — Moderate risk
Date Initiated March 18, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ROi CPS LLC
Location Republic, MO
Product Type Devices
Quantity 290 convenience kits

Product Description

Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.

Reason for Recall

A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.

Distribution Pattern

US Nationwide distribution in the state of Missouri.

Lot / Code Information

(1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 88219P, exp 6/30/2022; 89163, exp. 6/30/2022; 89430, exp. 5/31/2022; 89926, exp. 6/30/2022; 90372, exp, 6/30/2022; 91054, exp. 12/31/2022; and 91443, exp. 5/31/2023.

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.