Cordis US Corp: Angiographic Catheterization Sets Recalled for Loss of Sterility

Agency Publication Date: November 9, 2023

Summary

Cordis US Corp is recalling 30 units of their INFINITI THRULEMEN 5F Angiographic Catheterization Sets because products that were not sterile were incorrectly labeled and distributed as sterile. These cardiac catheters are used in medical procedures to visualize blood vessels, and the use of non-sterile equipment can lead to serious infections. Patients and healthcare providers should check their inventory for Lot Number 18223410 and refrain from using the affected devices. You should contact your healthcare provider or the manufacturer immediately if you have any questions regarding this recall.

Risk

The distribution of non-sterile medical devices labeled as sterile poses a critical risk of systemic infection or sepsis when the catheter is introduced into a patient's bloodstream during cardiac procedures.

What You Should Do

Immediately check your medical inventory for Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208 with Lot Number 18223410 and UDI/DI 10705032025935.
Identify and quarantine all affected units to ensure they are not used in any clinical or surgical procedures.
Contact Cordis US Corp at their facility located at 14201 Nw 60th Ave, Miami Lakes, Florida, 33014-2802, or call the manufacturer directly for instructions on returning the non-sterile products.
Consult with your healthcare provider if you have recently undergone a procedure involving an angiographic catheter and have concerns about potential infection.
For further information or to report any adverse events, 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

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

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

Affected Products

Product: Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Model / REF:

REF CO0208

UDI/DI 10705032025935

Lot Numbers:

18223410

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93174

Status: Active

Manufacturer: Cordis US Corp

Manufactured In: United States

Units Affected: 30 devices

Distributed To: Oklahoma

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

Immediately check your medical inventory for Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208 with Lot Number 18223410 and UDI/DI 10705032025935.

Identify and quarantine all affected units to ensure they are not used in any clinical or surgical procedures.

Contact Cordis US Corp at their facility located at 14201 Nw 60th Ave, Miami Lakes, Florida, 33014-2802, or call the manufacturer directly for instructions on returning the non-sterile products.

Consult with your healthcare provider if you have recently undergone a procedure involving an angiographic catheter and have concerns about potential infection.

For further information or to report any adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.