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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: Centurion Procedure Kits Recalled for Faulty Plastic Syringes

Agency Publication Date: August 7, 2024
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Summary

Medline Industries is recalling several Centurion medical procedure kits, including Neuro Angio and Central Venous Catheter (CVC) kits. These kits contain plastic syringes that have been identified as faulty due to potential leaks, breakage, and other quality issues as part of a wider FDA Safety Alert. Using these compromised syringes could lead to treatment delays or procedural complications, posing a risk to patient health. Consumers and healthcare providers should identify these specific kits by their pack and lot numbers and contact the manufacturer immediately.

Risk

The syringes included in these kits may leak or break during use. This can result in the loss of medication, the introduction of air into the patient's system, or delays in critical medical procedures.

What You Should Do

  1. Identify if you have the affected kits by checking for Pack Number DYNDA1431A (NEURO ANGIO PACK), Pack Number ECVC3260 (CVC INSERT BUNDLE 16CM), or Pack Number ECVC8105 (CVC DOUBLE LUMEN 16CM).
  2. Verify the lot numbers on your packaging: look for lot 2019072590 for Neuro Angio kits, lot 2021031650 for CVC Insert Bundles, or lot 2023012490 for CVC Double Lumen kits.
  3. Stop using these affected kits immediately and secure them to prevent further use.
  4. Contact Medline Industries, LP or your healthcare provider for further instructions on how to return the product or obtain a replacement.
  5. For additional questions, 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: Centurion procedure kits: NEURO ANGIO PACK
Model / REF:
DYNDA1431A
Lot Numbers:
2019072590
Product: Centurion procedure kits: CVC INSERT BUNDLE 16CM
Model / REF:
ECVC3260
Lot Numbers:
2021031650
Product: Centurion procedure kits: CVC DOUBLE LUMEN 16CM
Model / REF:
ECVC8105
Lot Numbers:
2023012490

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94584
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Authorized medical distributors
Manufactured In: United States
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.