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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 for Thin and Non-Uniform Skin Grafts

Agency Publication Date: October 6, 2023
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Summary

ROi CPS LLC is recalling 103 GS0008 2Y - Burn Packs (Item Number 880082025) because they contain Zimmer Dermatome Blades that were previously recalled by Zimmer. These specific blades have been linked to 38 complaints where skin grafts produced during surgery were dangerously thin or non-uniform. The affected convenience kits were distributed in Missouri and have an expiration date of July 16, 2025. Consumers and healthcare providers should check their inventory immediately for the specified lot number.

Risk

The affected surgical blades may produce skin grafts that are too thin or uneven, which can lead to poor surgical outcomes, delayed healing, or the need for additional medical procedures. There have been 38 reported complaints regarding the performance of these blades.

What You Should Do

  1. Immediately check your medical inventory for GS0008 2Y - Burn Pack - STL (Item Number 880082025).
  2. Verify if your kits match UDI/DI 10194717113805 and Lot Number 97289 with an expiration date of 2025-07-16.
  3. Stop using any kits identified as part of this recalled lot to prevent the use of the defective Zimmer Dermatome Blades.
  4. Contact your healthcare provider or ROi CPS LLC for specific instructions on how to return or dispose of the affected kits and to discuss potential refunds or replacements.
  5. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

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: GS0008 2Y - Burn Pack - STL (Item Number 880082025)
Model / REF:
880082025
UDI/DI 10194717113805
Lot Numbers:
97289
Date Ranges: Exp Date 2025-07-16

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93077
Status: Active
Manufacturer: ROi CPS LLC
Sold By: Medical facilities; Hospitals
Manufactured In: United States
Units Affected: 103 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 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.