US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      KELLY ( 22T010000 )

      Dated: JUN 23, 2022 Goodyear Tire & Rubber Company (Goodyear) is recalling certain Kelly Armorsteel KDM I tires, size 11R22.5 with DOT date code 3419. … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market

Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market

August 24, 2017 By The FDA Leave a Comment

On June 22, 2017, Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase.

A full list of affected products is attached. Products can be identified by the part number on the outer label of the package. Products in this recall were distributed globally.

Cook Medical has notified its customers and distributors by Medical Device Correction and Removal letters. All customers and distributors were informed to follow the IFU corrections, quarantine and discontinue use of the recalled sizes, and return that affected product to Cook as soon as possible for credit.

FDA and other regulatory agencies around the world have been notified of this action.

Consumers with questions or concerns should contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time. 

Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178.

Adverse events may also be reported to Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at [email protected].

###

Share this:

  • Facebook
  • Twitter
  • LinkedIn
  • Email
  • Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a Reply Cancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

KELLY ( 22T010000 )

July 7, 2022 By NHTSA

FORD ( 22V454000 )

July 7, 2022 By NHTSA

CUSTOM FIRE ( 22V461000 )

July 7, 2022 By NHTSA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

HYUNDAI ( 22V459000 )

July 7, 2022 By NHTSA

Bumble Bee Foods, LLC Issues Voluntary Recall on 3.75 Oz Smoked Clams Due to the Presence of Detectable Levels of PFAS Chemicals

July 6, 2022 By The FDA

FCCC ( 22V460000 )

July 6, 2022 By NHTSA

FREIGHTLINER ( 22V456000 )

July 6, 2022 By NHTSA

Primal Pet Foods Voluntary Recalls a Single Lot of Raw Frozen Patties Beef Formula Due to Potential Contamination with Listeria Monocytogenes

July 5, 2022 By The FDA

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

FREIGHTLINER ( 22V456000 )

July 6, 2022 By NHTSA

Primal Pet Foods Voluntary Recalls a Single Lot of Raw Frozen Patties Beef Formula Due to Potential Contamination with Listeria Monocytogenes

July 5, 2022 By The FDA

Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens

July 4, 2022 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • KELLY ( 22T010000 )
  • FORD ( 22V454000 )
  • CUSTOM FIRE ( 22V461000 )
  • GREAT DANE ( 22V448000 )
  • LINCOLN ( 22V455000 )
  • HYUNDAI ( 22V459000 )
  • Bumble Bee Foods, LLC Issues Voluntary Recall on 3.75 Oz Smoked Clams Due to the Presence of Detectable Levels of PFAS Chemicals
  • FCCC ( 22V460000 )
  • FREIGHTLINER ( 22V456000 )
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2022 Altrumedia · Terms of Service · Log in