BD Cathena Safety IV Catheters Recalled for Potential Blood Exposure Risk

Agency Publication Date: May 21, 2025

Summary

Becton Dickinson Infusion Therapy Systems, Inc. has recalled approximately 262,800 units of BD Cathena Safety IV Catheters due to a manufacturing defect. A hole may be present in the septum (seal), which can cause blood to leak during the insertion process. While no injuries have been reported, this defect may lead to accidental blood exposure for healthcare workers or require a second IV placement, potentially delaying medical treatment.

Risk

A hole in the catheter seal can cause blood to leak unexpectedly during use. This poses a risk of exposing medical staff or patients to bloodborne pathogens and may cause treatment delays if the device fails during insertion and must be replaced.

What You Should Do

This recall affects BD Cathena Safety IV Catheters with reference numbers (REF) 386865, 386803, and 386862. The specific lot numbers affected are 4198480, 4247809, and 4237744, with expiration dates ranging from June to August 2027.
Identify recalled products by checking the reference (REF) and lot numbers printed on the device packaging.
Stop using the recalled device immediately to avoid potential blood exposure or treatment delays.
Contact Becton Dickinson (BD) or your medical supply distributor to arrange for the return, replacement, or correction of the affected catheters.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or for help reporting any problems with the device.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN

Variants: 18 GA x 1.25 IN

Model / REF:

386865

Lot Numbers:

4198480 (Exp 30-Jun-2027)

UDI:

0100382903868650

Recall #: Z-1808-2025

Product: BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC

Variants: 20 GA x 1.00 IN, Straight BC

Model / REF:

386803

Lot Numbers:

4247809 (Exp 31-Aug-2027)

UDI:

0100382903868032

Recall #: Z-1808-2025

Product: BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN

Variants: 20 GA x 1.00 IN

Model / REF:

386862

Lot Numbers:

4237744 (Exp 31-Aug-2027)

UDI:

0100382903868629

Recall #: Z-1808-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96696

Status: Active

Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.

Sold By: Hospital supply distributors; Medical facilities

Manufactured In: United States

Units Affected: 262,800

Distributed To: Indiana, Alabama, California, Florida, Texas, New Jersey, Missouri, North Carolina, New York, Ohio, Arizona, Minnesota, Massachusetts, Washington, Oklahoma, Kansas, Mississippi, Louisiana, Maryland, Georgia, Tennessee, New Mexico, 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 · 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

What You Should Do

This recall affects BD Cathena Safety IV Catheters with reference numbers (REF) 386865, 386803, and 386862. The specific lot numbers affected are 4198480, 4247809, and 4237744, with expiration dates ranging from June to August 2027.

Identify recalled products by checking the reference (REF) and lot numbers printed on the device packaging.

Stop using the recalled device immediately to avoid potential blood exposure or treatment delays.

Contact Becton Dickinson (BD) or your medical supply distributor to arrange for the return, replacement, or correction of the affected catheters.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or for help reporting any problems with the device.

Affected Products

Product: BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN

Variants: 18 GA x 1.25 IN

Model / REF:

386865

Lot Numbers:

4198480 (Exp 30-Jun-2027)

UDI:

0100382903868650

Recall #: Z-1808-2025

Product: BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC

Variants: 20 GA x 1.00 IN, Straight BC

Model / REF:

386803

Lot Numbers:

4247809 (Exp 31-Aug-2027)

UDI:

0100382903868032

Recall #: Z-1808-2025

Product: BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN

Variants: 20 GA x 1.00 IN

Model / REF:

386862

Lot Numbers:

4237744 (Exp 31-Aug-2027)

UDI:

0100382903868629

Recall #: Z-1808-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96696

Status: Active

Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.

Sold By: Hospital supply distributors; Medical facilities

Manufactured In: United States

Units Affected: 262,800