Events

Recall of Device Recall KimVent Microcuff subglottic Suctioning Endotracheal Tube

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
    69910
  • Event Risk Class
    Class 1
  • Event Number
    Z-0868-2015
  • Event Initiated Date
    2014-11-17
  • Event Date Posted
    2014-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131946
  • 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
    Tube, tracheal (w/wo connector) - Product Code BTR
  • Reason
    The cuff inflation line may detach from the endotracheal tube during use.
  • Action
    The firm, Halyard Health, sent an "URGENT: VOLUNTARY PRODUCT RECALL" letter dated November 17, 2014 via FedEx to its Consignees/customers. The letter describes the product, problem and actions to be taken. 'the customers were instructed to please evaluate your facilities for unused inventory of KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes, if present, quarantine and discontinue use; complete the attached Distributor Product Recall Response Form via fax to: 678-254-0391 within five (5) business days of receipt of this letter; if you are in possession of the affected product lots, a Halyard Health representative will provide a return authorization and instructions on shipping product to a specified distribution center, and; follow your internal product recall procedures to identify and address affected product. If you require further assistance, please call Halyard Health Regulatory Affairs at 770-587-7400.

Device

Device Recall KimVent Microcuff subglottic Suctioning Endotracheal Tube
  • Model / Serial
    Product Code: 13223, Lot numbers: AA3203V03, AA3234, AA3234V01, AA3260, AA3260V01, AA4038, AA4038V01, AA4038V02, AA4038V05, AA4077, AA4077V01, AA4083, AA4083V01, AA4092V01 & AA4125V02.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.
  • Product Description
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. || Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
  • 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