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...]

      Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

      Summary Company Announcement Date: July 10, 2025 FDA Publish Date: July … [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 / BD Announces Worldwide Voluntary Recall ofBD Q-Sytea Luer Access Devices and BD Nexiva Closed IV Catheter Systems

BD Announces Worldwide Voluntary Recall ofBD Q-Sytea Luer Access Devices and BD Nexiva Closed IV Catheter Systems

February 10, 2010 By The FDA Leave a Comment

Becton, Dickinson and Company is recalling certain lots of BD Q-Syte ™ Luer Access Devices and BD Nexiva ™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action included notification to customers worldwide by letter. Neither the costs anticipated with the recall, nor the impact on BD’s business, are expected to be material.

The BD Q-Syte™ Luer Access device is intended for use with other infusion therapy products in the administration of fluids into the intravenous system. BD Nexiva has been added to the scope of this recall that was first initiated on Oct. 28, 2009. The BD Nexiva product has two BD Q-Syte devices within the package that could potentially be subject to the manufacturing deviation previously referenced in the Oct. 28, 2009 recall letter.

The following REF (catalog) and lot numbers, which were sold in the U.S., are included in the recall:

BD Q-Syte REF: 385100, 385101, 385102, 385108, 385150, 385151, 385164
Lot Numbers: 8268863, 8269020, 8275798, 8305510, 8305511, 8308321,
8308323,8308330, 8309553,8331937,8331940,8331944,8354558,8354561,
9007921,9009643,9009646,9028838,9035029,9035032,9012072,9007918,
9035042, 9035044, A1967, A1979, A2056, A1950, A2399, A1951

The following REF and lot numbers, which were sold outside of the U.S., are also
included in the recall:

BD Q-Syte REF: 380510,385100,385101
Lot Numbers: 8310565,8331938,8331946,9007907,9008474,9028892

The following REF (catalog) and lot numbers of BD Nexiva were sold in the u.s and
internationally and are included in the recall:

BD Nexiva REF: 383530, 383531, 383532, 383533, 383534, 383536, 383537, 383538,
383539,383540,383647,383649

Lot Numbers: 8238450, 8248349, 8248355, 8249034, 8249035, 8259950, 8263293, 8263294,8269338,8270576,8270579,8274555,8274565,8275207,8275210,8275429,8283964,
8284049,8284050,8290311,8291980,8295761,8296792,8296793,8305438,8308349,
8309299,309662,8311150,8311167,8312211,8312220,8319016,8319936,8319961,
8322609,8330279,8331763,8331771,8338737,8338738,8340302,8340308,8345951,
8345957,8347056,8347058,8358628,9007360,9013864,9013867,9013868,9015539,
9016819,9020033,9022039,9026722,9034319,9041552

Patient safety and the quality and safety of our products are BD’s first priorities. The recall was initiated on Oct. 28, 2009 after BD received complaints due to air entry through the bottom disk of the septum. BD investigated and determined the root cause to be a manufacturing deviation. Product failures occurred on lots ofBD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009. The root cause has been corrected and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented.

The approximately 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing 5 million BD Q-Syte devices that were recalled were distributed in the United States, Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America.
BD has notified the U.S. Food and Drug Administration and other worldwide health agencies, as necessary, and is working with them to coordinate recall activities. Clinicians or distributors with questions can contact BD at 1-800-453-4538, option 2, extension 2585, between 8:00 AM and 5:00 PM Mountain Standard Time, Monday-Friday, or dial directly at 1-801-565-2300, x2585 or x2860.

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

Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

July 10, 2025 By The FDA

Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination

July 10, 2025 By The FDA

Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards

July 9, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology

July 9, 2025 By The CPSC

AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA

July 9, 2025 By The CPSC

Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm

July 9, 2025 By The CPSC

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

CHS Inc. Recalls Payback Champion Lamb Feed Due to Elevated Copper Health Risk

July 9, 2025 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

  • Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
  • Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination
  • Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards
  • WLIVE Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon by WLIVE
  • Giant Bicycle Recalls Momentum Vida E+ E-Bikes Due to Crash Hazard
  • SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology
  • AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA
  • Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm
  • Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea
-- 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