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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

ROi CPS LLC: Regard Dressing Change Kits Recalled for Recalled Irrigation Component

Agency Publication Date: January 3, 2024
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Summary

ROi CPS LLC is recalling approximately 1,830 Regard Dressing change kits (Item Number 800026006) because they contain an irrigation solution component that was separately recalled by its own manufacturer. These convenience kits are used by healthcare providers and patients for medical dressing changes, but the included saline or irrigation solution may be compromised. Consumers and healthcare facilities should identify these kits by the item number and specific lot numbers listed below to prevent use of the faulty component.

Risk

The irrigation solution included in these kits was recalled by its original manufacturer, which could lead to patient infections or other complications if used during medical procedures. Using a compromised irrigation component during a dressing change poses a serious risk of introducing contaminants to sensitive or healing tissue.

What You Should Do

  1. Check your medical supplies for the Regard Dressing change kit, Item Number 800026006.
  2. Verify the lot numbers on the packaging to see if your kit is affected. Recalled lot numbers include: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, and 94270.
  3. Locate the UDI/DI 10194717107873 on the product label to further confirm the recall status.
  4. Stop using affected kits immediately and set them aside to ensure they are not used for patient care.
  5. Contact your healthcare provider or the manufacturer, ROi CPS LLC, for specific instructions on returning the product or obtaining a replacement.
  6. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer coordination

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

Affected Products

Product: Regard Dressing change kit
Model / REF:
800026006
UPC Codes:
10194717107873
Lot Numbers:
98283
97591
97405
97081
96961
95508
94769
94435
94270

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93525
Status: Resolved
Manufacturer: ROi CPS LLC
Sold By: medical distributors
Manufactured In: United States
Units Affected: 1830 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.