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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

ROi CPS LLC: Medical Convenience Kits Recalled Due to Faulty Syringes

Agency Publication Date: September 17, 2024
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Summary

ROi CPS LLC has recalled 3,387 medical convenience kits (regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE) because they contain syringes manufactured by Jiangsu Shenli Medical Production that were previously recalled for safety issues. These kits, used for medical procedures, were distributed in North Carolina. Consumers and healthcare providers should check their inventory immediately to identify affected kits and ensure the faulty syringes are not used during patient care.

Risk

The syringes included in these kits may have defects that could compromise their performance or safety during medical procedures, potentially leading to inaccurate dosing or other procedural complications.

What You Should Do

  1. Identify your kit by checking for the name 'regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE' and Item Number 800223009.
  2. Check the package for GTIN 10194717114116 and one of the following Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, or 96833RS.
  3. Immediately stop using any kits matching these identifiers and set them aside to prevent accidental use.
  4. Contact your healthcare provider or the manufacturer, ROi CPS LLC, at their Republic, Missouri office for specific instructions on how to handle or return the affected kits.
  5. For further information or to report concerns, 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

manufacturer or healthcare provider consultation

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

Affected Products

Product: regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE
Model / REF:
800223009
Z-3159-2024
UPC Codes:
10194717114116
Lot Numbers:
93697
94061
94452
94912
95813
96271
96464
96833
97051
97411
97893
98446
98913
99464
99912
100447
100757
101527
96833RS

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95229
Status: Active
Manufacturer: ROi CPS LLC
Sold By: ROi CPS LLC
Manufactured In: United States, China
Units Affected: 3387 kits
Distributed To: North Carolina

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.