Becton Dickinson Infusion Therapy Systems Inc.: BD Insyte Autoguard BC IV Catheters Recalled for Needle Retraction Failure

Agency Publication Date: November 24, 2023

Summary

Becton Dickinson (BD) is recalling 528,000 units of the BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology due to a defect where the needles may not retract properly into the safety barrel. This defect can lead to the catheter being accidentally removed from the insertion site, causing blood leaks or requiring multiple painful insertion attempts. Consumers should identify affected products by the specific lot number 3166524 and expiration date of May 31, 2026.

Risk

A needle that fails to retract poses a significant risk of contaminated needlestick injuries to healthcare providers or patients, potentially exposing them to bloodborne pathogens. Additionally, the defect can cause blood leakage at the insertion site or require repeated medical procedures to successfully place a new catheter.

What You Should Do

Identify if you have the affected product by checking the packaging for BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533.
Locate the lot number and expiration date on the individual sterile pouch or shelf carton to confirm it matches Lot: 3166524 with an Expiration Date of 2026/05/31.
If you identify an affected catheter, do not use it for patient care; set the product aside and quarantine it to prevent accidental use.
Contact your healthcare provider or Becton Dickinson Infusion Therapy Systems Inc. directly for instructions on returning the defective units and receiving further guidance.
For additional information or questions regarding this recall, 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

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: BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

Model / REF:

382533

Z-0400-2024

UPC Codes:

00382903825332

Lot Numbers:

3166524

Date Ranges: Expiration: 2026/05/31

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93276

Status: Active

Manufacturer: Becton Dickinson Infusion Therapy Systems Inc.

Sold By: Hospital supply distributors; Medical device wholesalers

Manufactured In: United States

Units Affected: 528,000

Distributed To: California, North Carolina, Michigan, Washington, Colorado, Florida, New Jersey, New Mexico, Illinois, Kentucky, Tennessee, Ohio, Texas, Indiana, Louisiana, Iowa, Mississippi, Missouri, Nebraska, Maryland, New York, Pennsylvania, Georgia, Virginia, Maine, South Carolina, Rhode Island, Massachusetts, Puerto Rico

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 · 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.

Summary

Risk

What You Should Do

Identify if you have the affected product by checking the packaging for BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533.

Locate the lot number and expiration date on the individual sterile pouch or shelf carton to confirm it matches Lot: 3166524 with an Expiration Date of 2026/05/31.

If you identify an affected catheter, do not use it for patient care; set the product aside and quarantine it to prevent accidental use.

Contact your healthcare provider or Becton Dickinson Infusion Therapy Systems Inc. directly for instructions on returning the defective units and receiving further guidance.

For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.