• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    PTI Engineered Plastics Inc.

    K-Tube Technologies

    Medbio LLC

    maxon

    Medicoil
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Qosina Corp.

    Element

    Concise Engineering

    Spectrum Plastics Group

    Unicep
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles

    The 20mm ChemoLock Vial Spike is intended to keep environmental contaminants like bacteria and dust out of a drug delivery system.

    Related CONTENT
    • Quantitative Transmission Ultrasound Outperforms Mammography
    • Preparing Your Design Controls for FDA Approval
    • Setting the Standard: Protective Nanocoatings for Today's Medtech
    • Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve
    • How Design Controls Can Prevent Medical Device Recalls
    U.S. Food and Drug Administration02.25.19
    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
     
    Recalled Product(s)
     
    • ChemoLock Vial Spike, 20mm
    • Lot Number: 3757712
    • Manufacturing Dates: August 13, 2018 to August 13, 2018
    • Distribution Dates: August 2018 to September 2018. 
    • Devices Recalled in the U.S.: 2050 Units of CL-80S ChemoLock Vial Spike
     
    The 20mm ChemoLock Vial Spike is intended to keep environmental contaminants—like bacteria and dust—out of a drug delivery system and to prevent drug or vapor concentrations from leaking out of the system. The device consists of a spike and clasp which penetrates the drug container as well as a cap which protects the spike prior to use.
    ChemoLock is used by health care professionals in compounding pharmacies and health care facilities.
     
    ICU Medical is recalling one lot of ChemoLock Vial Spikes, 20mm due to the potential for plastic particles to break off the protective cap. In uncommon circumstances, a plastic particle could enter the drug delivery system and be infused into a patient's intravenous line, which could potentially enter the patient and lead to an embolism.

    To date, ICU Medical has not received any reports of adverse events related to this issue, although the risk of introducing foreign particulates into the patient's body, can cause serious injury or death.
     
    Healthcare facilities (for example, hospitals and clinics) and healthcare professionals using ChemoLock Vial Spike and patients receiving medication from a ChemoLock Vial Spike may be affected.
     
    On January 3, 2019, ICU Medical sent customers an “Urgent Medical Device Recall” letter. The letter instructed customers to:
     
    • Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility
    • Inform potential users of the product in your organization of this notification.
    • Complete and return the Medical Device Recall Response form enclosed with the firm's recall letter. (Fax the completed form to 1-855-497-9856 or e-mail the form to ICUMEDICAL6834@stericycle.com, even if you do not have the affected product.)
    • Return affected product using the return label provided with the firm's recall letter. Contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product.
    • If you have distributed the product further, immediately notify your accounts that received the product identified in this recall and ask them to contact Stericycle at 1-888-871-7114 (M-F, 8am-5pm ET) to obtain a response form.
     
    Customers who have questions or need additional information regarding this recall may contact ICU Medical Customer Care at 1-949-366-4208.
     
    The recall was initiated January 14, 2019
    Related Searches
    • icu medical
    • ul
    • drug delivery
    • recalls
    Related Knowledge Center
    • Packaging & Sterilization
    Suggested For You
    Quantitative Transmission Ultrasound Outperforms Mammography Quantitative Transmission Ultrasound Outperforms Mammography
    Preparing Your Design Controls for FDA Approval Preparing Your Design Controls for FDA Approval
    Setting the Standard: Protective Nanocoatings for Today Setting the Standard: Protective Nanocoatings for Today's Medtech
    Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve
    How Design Controls Can Prevent Medical Device Recalls How Design Controls Can Prevent Medical Device Recalls
    The Top 30 and M&A in 2021: What’s Next? The Top 30 and M&A in 2021: What’s Next?
    Global Central Venous Catheter Market to Surpass $3.06 Billion by 2027 Global Central Venous Catheter Market to Surpass $3.06 Billion by 2027
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    FDA OKs SentiAR FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter
    FDA Clears Scientia Vascular FDA Clears Scientia Vascular's Zoom Wire
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    FDA OKs Surmodics FDA OKs Surmodics' Pounce Thrombus Retrieval System
    FDA Launches the Digital Health Center of Excellence FDA Launches the Digital Health Center of Excellence

    Related Breaking News

    • Packaging & Sterilization
      STERIS to Buy Cantel Medical for $4.6B

      STERIS to Buy Cantel Medical for $4.6B

      Complementary to STERIS’s product and service portfolio, focused on infection prevention.
      GlobeNewswire 01.12.21

    • Packaging & Sterilization | Surgical
      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.
      Olympus 01.06.21

    • Packaging & Sterilization
      Nelipak Promotes President & COO to CEO

      Nelipak Promotes President & COO to CEO

      Pat Chambliss will succeed Roger Prevot as the company’s CEO.
      Globe Newswire 01.04.21


    • Packaging & Sterilization
      Centerpiece to Open New North American ETO Sterilization Facility

      Centerpiece to Open New North American ETO Sterilization Facility

      The company will launch the new ethylene-oxide sterilization facility in Tijuana, Mexico early next year.
      Centerpiece 12.14.20

    • Packaging & Sterilization
      Spectrum Plastics Group Acquires PeelMaster Medical Packaging Corporation

      Spectrum Plastics Group Acquires PeelMaster Medical Packaging Corporation

      Increases its sterile medical flexible packaging capabilities.
      Spectrum Plastics Group 12.02.20

    • Packaging & Sterilization
      Brenda Chamulak named President of Tekni-Plex Packaging Products

      Brenda Chamulak named President of Tekni-Plex Packaging Products

      Comes from Jabil Packaging Solutions where she was CEO, SVP and president.
      Tekni-Plex 10.08.20


    • Packaging & Sterilization
      Sotera Health Acquires Iotron Industries

      Sotera Health Acquires Iotron Industries

      Complements Sotera Health's Sterigenics business.
      PRNewswire 08.03.20

    • Packaging & Sterilization

      'Bug Zapper' UV-C Light Enables N95 Mask Sterilization, Reuse

      Can decontaminate 200 N95 masks every eight minutes.
      Lehigh University 05.11.20

    • Packaging & Sterilization
      FDA OKs ASP

      FDA OKs ASP's STERRAD Cycles to Sterilize N95 Respirators

      Has potential to decontaminate four million N95 or N95-equivalent respirators per day in the U.S.
      U.S. Food and Drug Administration 04.13.20


    • Packaging & Sterilization
      FDA OKs STERIS Systems to Decontaminate N95 Respirators

      FDA OKs STERIS Systems to Decontaminate N95 Respirators

      Will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
      U.S. Food and Drug Administration 04.13.20

    • Packaging & Sterilization
      FDA Clears 15-Minute Hydrogen Peroxide Sterilization System

      FDA Clears 15-Minute Hydrogen Peroxide Sterilization System

      Advanced Sterilization Products claims process is 38 percent faster than competitors.
      Business Wire 03.09.20

    • Packaging & Sterilization
      EPA Ethylene Oxide Value at Odds with Public Health

      EPA Ethylene Oxide Value at Odds with Public Health

      AdvaMed calls for revision to EtO risk assessment standard.
      AdvaMed 02.19.20


    • Packaging & Sterilization
      QTS Receives MedAccred Accreditation

      QTS Receives MedAccred Accreditation

      Receives Global First in Sterile Device Packaging accreditation.
      Quality Tech Services 01.29.20

    • Packaging & Sterilization
      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      EGLE had been investigating over the past year and issued Viant several violations for inadequate capture and control of ethylene oxide emissions.
      Michigan Department of Environment, Great Lakes, and Energy (EGLE) 12.04.19

    • Packaging & Sterilization | Surgical
      Devices Modified with Nanoscale Beam Thwart Dangerous Bacteria

      Devices Modified with Nanoscale Beam Thwart Dangerous Bacteria

      Practical use of the technology is believed to be close at hand.
      AVS: Science and Technology of Materials, Interfaces, and Processing 10.28.19


    Trending
    • Meeting Critical Ventilator Product Requirements Amid Pandemic
    • STERIS To Buy Cantel Medical For $4.6B
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Medtech Matters: Talking Robotic Surgery With Zimmer Biomet
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    What You're Reading on Happi.com
    Amyris Named a Top Social & Environmental Impact Company
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login