ROi CPS LLC: Regard Kits Recalled Due to Compromised Sterile Packaging

Agency Publication Date: August 16, 2024

Summary

ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters because the sterile packaging may have pin holes and tears that cannot be seen. These kits were distributed in Missouri and include two specific lot numbers with expiration dates in September 2024. Because the packaging may be compromised, the decanter inside may no longer be sterile, potentially leading to infections during medical procedures. Consumers should immediately stop using these kits and contact the manufacturer for further instructions.

Risk

Invisible holes or tears in the packaging compromise the sterile barrier of the medical device, which can introduce contaminants and bacteria into a sterile field, posing a risk of infection to patients.

What You Should Do

Identify your product by checking the packaging for Regard Kit containing the Microtek decanter with Item Number 830099009 and UDI 10194717116677.
Check the labels for Lot numbers 99206 or 100633, both of which have an Expiration Date of 2024-09-15.
Immediately stop using any affected kits and quarantine them to ensure they are not used in clinical settings.
Contact the manufacturer, ROi CPS LLC, to report your affected stock and receive instructions on the return or replacement process.
Consult a healthcare provider if you have concerns regarding a procedure where this device may have been used.
For further questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer contact and medical guidance

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

Affected Products

Product: Regard Kit containing the Microtek decanter

Model / REF:

830099009

UDI: 10194717116677

Lot Numbers:

99206 (Expiration Date: 2024-09-15)

100633 (Expiration Date: 2024-09-15)

Date Ranges: Expiration Date: 2024-09-15

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94999

Status: Active

Manufacturer: ROi CPS LLC

Sold By: ROi CPS LLC

Manufactured In: United States

Units Affected: 78 Kits

Distributed To: Missouri

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 · 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.

Summary

What You Should Do

Identify your product by checking the packaging for Regard Kit containing the Microtek decanter with Item Number 830099009 and UDI 10194717116677.

Check the labels for Lot numbers 99206 or 100633, both of which have an Expiration Date of 2024-09-15.

Immediately stop using any affected kits and quarantine them to ensure they are not used in clinical settings.

Contact the manufacturer, ROi CPS LLC, to report your affected stock and receive instructions on the return or replacement process.

Consult a healthcare provider if you have concerns regarding a procedure where this device may have been used.

For further questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.