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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

ROi CPS LLC: Surgical Convenience Kits Recalled Due to Recalled Component

Agency Publication Date: January 12, 2024
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Summary

ROi CPS LLC is recalling 345 units of the regard Operative LAP (Item Number 800943001) surgical convenience kits. These kits were manufactured using a specific component that was subsequently recalled by its original manufacturer, Nurse Assist. Consumers should contact their healthcare provider or the manufacturer regarding this recall, as the safety and sterility of the affected kits may be compromised.

Risk

The kits contain a component previously recalled by Nurse Assist, which may pose a risk of patient injury or infection if the component does not meet safety or sterility standards. No specific injuries have been reported in this notice, but the recall is classified as critical due to the potential medical risks involved in surgical settings.

What You Should Do

  1. Identify if you have the affected regard Operative LAP surgical convenience kits by checking for Item Number 800943001.
  2. Verify the Lot Numbers and UDI on the product packaging: look for Lot Numbers 94792, 95613, 96003, or 96845, and UDI/DI 10194717111863.
  3. If you have an affected kit, immediately stop using it and set it aside to ensure it is not used in any medical procedures.
  4. Contact your healthcare provider or ROi CPS LLC for further instructions regarding the return or disposal of the affected kits and potential replacement or refund.
  5. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: regard Operative LAP surgical convenience kit
Model / REF:
800943001
Lot Numbers:
94792
95613
96003
96845
UDI/DI 10194717111863

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93653
Status: Resolved
Manufacturer: ROi CPS LLC
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 345 units
Distributed To: Louisiana

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.