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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

Becton Dickinson Infusion Therapy Systems, Inc.: BD Insyte Autoguard BC Catheters Recalled for Tubing Holes and Leaks

Agency Publication Date: July 31, 2024
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Summary

Becton Dickinson (BD) is recalling 26,400 units of the BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology because the catheter tubing may contain a hole. This defect can cause fluids to leak during the catheter insertion process. These prescription devices are used by healthcare professionals to sample blood, monitor blood pressure, or administer fluids into a patient's peripheral vascular system.

Risk

A hole in the catheter tubing can lead to the leakage of blood or medication during insertion, which could potentially expose healthcare providers to bloodborne pathogens or result in the inadequate delivery of fluids or medication to the patient.

What You Should Do

  1. Locate the catheter packaging and verify if it is the BD Insyte Autoguard BC, Shielded IV Catheter (20 GA x 1.00 in, 63 mL/min).
  2. Check the packaging for Lot Number 4127714 and the UDI-DI code 00382903825332 to determine if your specific unit is affected.
  3. Immediately stop using any catheters identified as part of Lot Number 4127714.
  4. Contact your healthcare provider or Becton Dickinson (BD) directly to report the affected product and receive further instructions on how to return or dispose of the units.
  5. For additional information or questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Professional consultation and manufacturer guidance

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

Affected Products

Product: BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min
Model / REF:
REF: 382533
UDI-DI: 00382903825332
Lot Numbers:
4127714

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94896
Status: Active
Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.
Sold By: Healthcare facilities; Medical distributors
Manufactured In: United States
Units Affected: 26,400 units
Distributed To: Illinois

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.