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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/Home Healthcare

MEDLINE INDUSTRIES, LP - Northfield: HUDSON RCI Addipak Vials Recalled for Potential Sterility Failure

Agency Publication Date: September 14, 2023
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Summary

Medline Industries, LP is recalling approximately 18,000 units of HUDSON RCI Addipak Unit Dose Vials (5mL Sterile 0.9% NaCl Solution for Inhalation USP) because the product was accidentally shipped to customers after it had been marked for disposal. The vials were originally flagged for scrap following an investigation into potential sterility failures. Consumers should immediately stop using the affected vials as they may not be sterile, which can lead to serious health complications when inhaled.

Risk

The use of a non-sterile inhalation solution can introduce bacteria or other contaminants directly into the lungs, potentially causing severe respiratory infections or other life-threatening illnesses, especially in vulnerable patients.

What You Should Do

  1. Check your supply for HUDSON RCI Addipak Unit Dose Vials, 5mL Sterile 0.9% NaCl (Saline) Solution for Inhalation USP (Reference Number RHUD59U).
  2. Verify the specific identification codes on the packaging: look for UDI/DI 140267047147818 and Lot code 3B085.
  3. Immediately stop using any vials that match the Lot code 3B085.
  4. Contact your healthcare provider or the manufacturer, Medline Industries, at 1-800-MEDLINE for further instructions regarding the disposal or return of the affected product and to discuss potential refund options.
  5. If you have used this product and experience any symptoms of a respiratory infection, contact your healthcare provider immediately.
  6. For additional questions or to report a problem, contact the FDA's medical device hotline 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

Consult healthcare provider or manufacturer

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

Affected Products

Product: HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP
Model / REF:
RHUD59U
UPC Codes:
140267047147818
Lot Numbers:
3B085

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92834
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Authorized distributors; Medical supply retailers
Manufactured In: United States
Units Affected: 18,000 units
Distributed To: Nationwide

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.