Healthcare Purchasing News
  • Magazine
  • Continuing Education
  • Webinars
  • Whitepapers
  • Videos
  • Events
  • Hall of Fame
  • Advertise
  • Source Guide
  • Subscribe
  • Sourcing & Logistics
  • Sterile Processing
  • Surgical & Critical Care
  • Patient Satisfaction
  • Infection Prevention
  • EVS & Facility Services
  • Healthcare IT
  • Regulatory
  • Topics
    Sourcing & LogisticsSterile ProcessingSurgical & Critical CarePatient SatisfactionInfection PreventionEVS & Facility ServicesHealthcare ITRegulatory
    Resources
    HPN Source GuideContinuing EducationWebinarsWhitepapersVideosEventsHall of FameAdvertiseAd Specs
    User Tools
    SubscribeContact UsAbout UseNewsletterMagazinesPrivacy PolicyTerms & Conditions
    https://www.facebook.com/hpnonline
    https://www.linkedin.com/company/healthcare-purchasing-news/
    https://twitter.com/HPN_Online
    1. Surgical/Critical Care
    2. Med-Surg Equipment

    FDA Class I Recall: Medical Action Industries, Inc. 306 Medical Convenience Kits for risk of fungal contamination

    May 25, 2021
    Image by Kristijan Puljek from Pixabay
    Fda Class I Recall Medical Action Industries, Inc 306 Medical Convenience Kits For Risk Of Fungal Contamination Pic 5 25 21du Stop 2717058 1280 Pixabay

    The Food and Drug Administration (FDA) announced Medical Action Industries is recalling the Medical Convenience Kits that include the BD/Carefusion Chloraprep 3mL applicator due to the risk of contamination with a specific type of fungus called Aspergillus penicillioides.

    The FDA has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death. There have been no deaths, complaints, or reported injuries related to this issue.

    If skin preparation products are contaminated with Aspergillus penicillioides, the fungus can cause serious systemic infection, sepsis, illness, and death to the patient. If the fungus is introduced in the patient’s bloodstream during placement of an intravascular catheter, the catheter may need to be removed, requiring additional medical procedures. If the fungus infects a surgical site, the patient may require medical and surgical treatments and require long-term treatment with antifungal drugs.

    Recalled Product:

    Medical Action Industries, Inc. 306 Medical Convenience Kits

    Kit Models and Lot Numbers: Please see links below.

    Distribution Dates: December 12, 2019 to March 22, 2021

    Devices Recalled in the U.S.: 8,210

    Date Initiated by Firm: April 9, 2021

    Medical Action Industries’ Medical Convenience Kits include a set of devices that are used to complete routine medical care such as:

    ·        Dressing changes around a central line, a catheter in a large vein that delivers fluids and allows blood draws

    ·         Injections

    ·         Midline catheter insertion to deliver medications or fluids into a vein

    ·         Dressing changes for left ventricular assist devices, a type of heart pump

    ·         Collection of blood cultures to test for infections

    Each convenience kit listed above includes a Chloraprep 3 mL applicator, which is used to sanitize skin prior to wound care, catheter procedure or blood collection. The Chloraprep 3 mL applicator is manufactured by another firm, BD/Carefusion 213.

    FDA has the recall.

    Latest in Med-Surg Equipment

    178865321 © Ratz Attila | Dreamstime.com
    Dreamstime Xxl 178865321
    Med-Surg Equipment

    FDA removes certain ventilation-related products from the medical device shortage list

    Oct. 23, 2023
    By HENADZY on AdobeStock
    Adobe Stock 362522872
    Surgical Instruments

    TELA Bio’s technology proves beneficial in hernia repairs, studies show

    Aug. 5, 2022
    By romaset on AdobeStock
    Adobe Stock 272220138
    Med-Surg Equipment

    US Med-Equip announces acquisition of Freedom Medical

    Aug. 3, 2022
    By adrian_ilie825 on AdobeStock
    Adobe Stock 165231787 (1)
    Med-Surg Equipment

    FDA Class I recall: Baxter Healthcare’s Volara system

    June 24, 2022
    By MIA Studio on AdobeStock
    Adobe Stock 386683079
    Med-Surg Equipment

    Decreasing stroke rates for children with artificial heart pumps

    June 23, 2022
    Healthcare Purchasing News
    https://www.facebook.com/hpnonline
    https://www.linkedin.com/company/healthcare-purchasing-news/
    https://twitter.com/HPN_Online
    • About Us
    • Contact Us
    • Advertise
    • Do Not Sell or Share
    • Privacy Policy
    • Terms & Conditions
    © 2023 Endeavor Business Media, LLC. All rights reserved.
    Endeavor Business Media Logo