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...]

      509 Recalls Helmets Due to Risk of Head Injury

      The recalled helmets fail to provide sufficient protection in the event of a crash, posing a risk of head injury. … [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 / Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters

Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters

May 16, 2008 By The FDA Leave a Comment

CONTACT: ATRIUM 1-800-5-ATRIUM

FOR IMMEDIATE RELEASE — HUDSON, NEW HAMPSHIRE – MAY 12, 2008 – ATRIUM MEDICAL CORPORATION TODAY ANNOUNCED THAT IT IS INITIATING A VOLUNTARY AND PRECAUTIONARY RECALL OF SELECTED LOTS OF HYDRAGLIDE™ BRAND HEPARIN-COATED THORACIC DRAINAGE CATHETERS. LIMITED LOTS OF ATRIUM HEPARIN-COATED HYDRAGLIDE THORACIC CATHETERS WERE MANUFACTURED WITH HEPARIN FOUND TO HAVE BEEN CONTAMINATED WITH OVERSULFATED CHONDROITIN SULFATE (OSCS). THE PATIENT RISK ASSOCIATED WITH THE PRESENCE OF OSCS IN HEPARIN-COATED MEDICAL DEVICES IS NOT KNOWN AT THIS TIME. THE U.S. FOOD AND DRUG ADMINISTRATION HAS RECEIVED REPORTS OF SERIOUS INJURY AND DEATH IN PATIENTS WHO HAVE BEEN ADMINISTERED INJECTABLE HEPARIN PRODUCTS CONTAINING HIGH LEVELS OF OSCS. WHILE ATRIUM’S HYDRAGLIDE CATHETERS DO NOT CONTAIN HIGH LEVELS OF HEPARIN, THERE STILL EXISTS A POTENTIAL EXPOSURE OF OSCS TO THE PATIENT.

CUSTOMERS WITH AFFECTED LOTS ARE ADVISED TO IMMEDIATELY DISCONTINUE USE OF THESE DEVICES AND OBTAIN REPLACEMENT CATHETERS FROM ATRIUM. ATRIUM WILL BE WORKING WITH OUR CUSTOMERS TO REPLACE THE AFFECTED PRODUCT AS SOON AS POSSIBLE. IF A NON-ELECTIVE PROCEDURE REQUIRES USE OF THIS CATHETER, WE RECOMMEND THAT YOU DO NOT USE THE CATHETER WITH EITHER A CELL SAVER AUTOTRANSFUSION SYSTEM OR DIRECT AUTOTRANSFUSION CHEST DRAINAGE COLLECTION SYSTEM FOR CARDIOPULMONARY BYPASS SURGERY.

ATRIUM HAS NOT RECEIVED REPORTS OF ANY OSCS-RELATED ADVERSE EVENTS ARISING FROM ANY USE OF THEIR HYDRAGLIDE THORACIC CATHETERS. THIS VOLUNTARY RECALL IS BEING INITIATED AS A PRECAUTION TO MINIMIZE ANY FUTURE POTENTIAL RISK.

THE ABOVE CUSTOMER NOTIFICATION ACTIONS ARE BEING TAKEN WITH THE KNOWLEDGE OF THE U.S. FOOD AND DRUG ADMINISTRATION. PHYSICIANS AND HOSPITAL PERSONNEL WITH PRODUCT RELATED QUESTIONS SHOULD CALL THE COMPANY AT 1-800-5-ATRIUM, MONDAY –FRIDAY, 8:00 AM TO 5:00 PM EST.

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) 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 ReplyCancel 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

509 Recalls Helmets Due to Risk of Head Injury

July 2, 2025 By The CPSC

SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi

July 2, 2025 By The CPSC

Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard

July 2, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop

July 2, 2025 By The CPSC

Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard

July 2, 2025 By The CPSC

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

June 27, 2025 By The FDA

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

iHerb Recalls Bottles and Blister Packs of California Gold Nutrition Iron Supplements Due to Risk of Serious Injury or Death from Child Poisoning; Violation of Federal Standard for Child Resistant Packaging

June 25, 2025 By The CPSC

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

  • 509 Recalls Helmets Due to Risk of Head Injury
  • SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi
  • Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard
  • DEWALT Recalls Grinder Flap Discs Due to Laceration and Injury Hazards
  • Trane Recalls Gas/Electric Packaged Units Due to Risk of Gas Leak, Fire Hazard
  • Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop
  • Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard
  • Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
  • Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
-- 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 © 2025 Altrumedia · Terms of Service · Log in