Events

Recall of Device Recall KimVent Closed Suction System for Neonates/Pediatrics

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
    71966
  • Event Risk Class
    Class 2
  • Event Number
    Z-2521-2015
  • Event Initiated Date
    2015-07-29
  • Event Date Posted
    2015-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139524
  • 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 thumb valve of some kimvent closed suction systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "locked" position.
  • Action
    Halyard sent a Product Advisory Notice on July 29, 2015, via FEDEX with a second letter dated August 12, 2015, being issued via FEDEX. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to report any occurrence of a valve leak to Halyard Customer Service at 1-844-425-9273, option 1, option 3.

Device

Device Recall KimVent Closed Suction System for Neonates/Pediatrics
  • Model / Serial
    Product Code 201 - M5076T405
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
  • Product Description
    KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) || A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
  • Manufacturer
    Halyard Health, Inc

Manufacturer

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