Events

Recall of Device Recall KimVent

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

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
    70397
  • Event Risk Class
    Class 2
  • Event Number
    Z-1222-2015
  • Event Initiated Date
    2015-01-16
  • Event Date Posted
    2015-02-27
  • 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=133454
  • 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
    Defect: a hole or crack was found which may cause air to leak.
  • Action
    Consignees were notified by letter via FedEx on 01/16/2015.

Device

Device Recall KimVent
  • Model / Serial
    Product Code; 22108147, Wet Pak Lot number: AB4195U14, AB4216U06 & AB4230U16, KimVent Lot Number: M4132T643.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
  • Product Description
    KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
  • Manufacturer
    Halyard Health

Manufacturer

Halyard Health
  • Manufacturer Address
    Halyard Health, 1400 Holcomb Bridge Rd, Roswell GA 30076-2190
  • Manufacturer Parent Company (2017)
    Halyard Health Inc
  • Source
    USFDA