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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

MEDLINE INDUSTRIES, LP - Northfield: Namic Convenience Kits and Fluid Delivery Sets Recalled for Sterility Issues

Agency Publication Date: May 10, 2024
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Summary

Medline Industries, LP is recalling approximately 620 units of various Namic surgical kits and fluid delivery sets because they lack assurance of sterility. These medical kits, which include components for heart and carotid procedures, may contain contaminated equipment that could lead to serious infections if used during surgery. The recall affects 570 Convenience Kits and 50 Fluid Delivery Sets distributed across multiple states.

Risk

A lack of sterility assurance means the products may have been exposed to bacteria or other pathogens. If these non-sterile devices are used during invasive medical procedures, patients are at risk of developing healthcare-associated infections or other serious complications.

What You Should Do

  1. Identify your product by checking the packaging for the name 'namic CONVENIENCE KIT' or 'Namic FLUID DELIVERY SET'.
  2. Check your kit for specific Reference (REF) and Lot numbers. Affected kits include Carotid Manifold (REF 60011045, Lot 0000113192), 3V Manifold (REF 60070582, Lot 0000113331), and Left Heart Kits (REF 60071822, Lot 0000112999; REF 60080085, Lot 0000113000; REF 600705710, REF 60131446, REF 60183972, REF 60032582A).
  3. For the Fluid Delivery Set (REF 91300040), look for Lot Number 0000113381 and UDI/DI 20193489069096 (box) or 10193489069099 (unit).
  4. Immediately stop using any products identified as part of this recall and quarantine them to prevent accidental use.
  5. Contact your healthcare provider or Medline Industries, LP at their Northfield, Illinois headquarters for instructions on returning the affected products and obtaining replacements or refunds.
  6. For additional information, contact the FDA's medical device recall line 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: namic CAROTID MANIFOLD KIT
Model / REF:
REF 60011045
UPC Codes:
10193489040456
Lot Numbers:
0000113192
Product: namic 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT
Model / REF:
REF 60070582
UPC Codes:
10193489044195
Lot Numbers:
0000113331
Product: namic LEFT HEART KIT (REF 60071822)
Model / REF:
REF 60071822
UPC Codes:
10193489044386
Lot Numbers:
0000112999
Product: namic LEFT HEART KIT (REF 60080085)
Model / REF:
REF 60080085
UPC Codes:
10193489044416
Lot Numbers:
0000113000
Product: namic CONVENIENCE KIT (REF 60100055)
Model / REF:
REF 60100055
UPC Codes:
10193489044935
Lot Numbers:
0000113187
Product: Namic FLUID DELIVERY SET
Model / REF:
REF 91300040
UPC Codes:
20193489069096
10193489069099
Lot Numbers:
0000113381
Product: namic 3 VALVE MANIFOLD OFF KIT
Model / REF:
REF 60140798

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94313
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Direct distribution to healthcare facilities
Manufactured In: United States
Units Affected: 2 products (570 units; 50 units)
Distributed To: Alabama, Florida, Kentucky, Mississippi, Texas, Washington, Wisconsin, North Carolina, Virginia, California, South Dakota, Tennessee, Georgia, Pennsylvania

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.