Cook Medical Incorporated: EchoTip Endoscopic Ultrasound Access Needles Recalled for Bacterial Endotoxins

Agency Publication Date: May 16, 2024

Summary

Cook Medical Incorporated is recalling EchoTip Ultra and EchoTip Ultra HD Endoscopic Ultrasound Access Needles because they may contain elevated levels of bacterial endotoxins. This recall affects a total of 9 units that were distributed internationally to Germany, the Netherlands, Switzerland, and the United Kingdom. These specialized medical needles are used in endoscopic ultrasound procedures, and the presence of endotoxins can cause serious health complications for patients during surgery.

Risk

Exposure to elevated levels of bacterial endotoxins in a medical device can trigger a systemic inflammatory response, leading to symptoms such as high fever, chills, low blood pressure, and in severe cases, septic shock or death.

What You Should Do

Identify if you have the EchoTip Ultra HD Endoscopic Ultrasound Access Needle (Model ECHO-HD-19-A) with Lot Numbers C2145003 or C2144407 and UDI 00827002520127.
Identify if you have the EchoTip Ultra Endoscopic Ultrasound Access Needle (Model ECHO-19) with Lot Numbers C2145003 or C2144407 and UDI 00827002315204.
Immediately stop using any affected needles and quarantine them to prevent clinical use.
Contact your healthcare provider or Cook Medical Incorporated directly for instructions on how to return the affected units and to discuss any necessary patient follow-up.
Healthcare professionals or consumers with questions can contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

Other Action

Manufacturer notification and device quarantine

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

Affected Products

Product: EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Model / REF:

ECHO-HD-19-A

G52012

UPC Codes:

00827002520127

Lot Numbers:

C2145003

C2144407

Product: EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

Model / REF:

ECHO-19

G31520

UPC Codes:

00827002315204

Lot Numbers:

C2145003

C2144407

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94395

Status: Active

Manufacturer: Cook Medical Incorporated

Sold By: Specialized medical distributors

Manufactured In: United States

Units Affected: 2 products (1 Unit OUS; 8 units OUS)

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

Identify if you have the EchoTip Ultra HD Endoscopic Ultrasound Access Needle (Model ECHO-HD-19-A) with Lot Numbers C2145003 or C2144407 and UDI 00827002520127.

Identify if you have the EchoTip Ultra Endoscopic Ultrasound Access Needle (Model ECHO-19) with Lot Numbers C2145003 or C2144407 and UDI 00827002315204.

Immediately stop using any affected needles and quarantine them to prevent clinical use.

Contact your healthcare provider or Cook Medical Incorporated directly for instructions on how to return the affected units and to discuss any necessary patient follow-up.

Healthcare professionals or consumers with questions can contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Affected Products

Product: EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Model / REF:

ECHO-HD-19-A

G52012

UPC Codes:

00827002520127

Lot Numbers:

C2145003

C2144407

Product: EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

Model / REF:

ECHO-19

G31520

UPC Codes:

00827002315204

Lot Numbers:

C2145003

C2144407