Events

Recall of KimVent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Halyard Health, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71110
  • Event Risk Class
    Class 2
  • Event Number
    Z-1678-2015
  • Event Initiated Date
    2015-04-14
  • Event Date Posted
    2015-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136144
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheters, suction, tracheobronchial - Product Code BSY
  • Reason
    The internal blue flapper valve of certain kimvent turbo-cleaning closed suction system for adults may have a potential defect. if present, the defect potentially allows air to leak out of the closed ventilator circuit.
  • Action
    Halyard Health Regulatory Affairs sent an Urgent Voluntary Product Recall letter dated April 16, 2015, to all affected consignees. Consignees were instructed to quarantine and discontinue use of the recalled product. Specific return instructions were provided in the Notice. The consignees were also requested to provide a response to to the recall notification. Wholesalers were instructed to follow their internal recall procedures to identify and address affected products. Consignees with questions were instructed to call Halyard Health Regulatory Affairs at 470-448-5700.

Device

KimVent
  • Model / Serial
    M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
  • Product Description
    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
  • Manufacturer
    Halyard Health, Inc

Manufacturer

Halyard Health, Inc
  • Manufacturer Address
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA