Events

Recall of Device Recall Parker TrachVac Endotracheal Tubes

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

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
    74547
  • Event Risk Class
    Class 2
  • Event Number
    Z-2243-2016
  • Event Initiated Date
    2016-06-02
  • Event Date Posted
    2016-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147877
  • 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
    Parker medical announces a voluntary field action for the parker trach-vac endotracheal tubes - (endotracheal tube,with parker flex-tip,sub-glottic suction, high volume low pressure) due to tube kinking during use.
  • Action
    Customers were notified on June 2, 2016 that a recall was initiated via telephone. The information communicated identified the affected product, problem and actions to be taken. Customers were instructed to segregate the affected product for immediate pick-up. A Sales Representatives went to each hospital and retrieved all unused product.

Device

Device Recall Parker TrachVac Endotracheal Tubes
  • Model / Serial
    Model Number: H-PFTVPU-60; H-PFTVPU-65; H-PFTVPU-70; H-PFTVPU-75; H-PFTVPU-80; H-PFTVPU-85; H-PFTVPU-90; H-PFTVVC-60; H-PFTVVC-65; H-PFTVVC-70; H-PFTVVC-75; H-PFTVVC-80; H-PFTVVC-85; H-PFTVVC-90  Lot Numbers: 1512TVC2029I through 1512TVC2029O (I, J, K, L, M, N, O); 1602TVC0226I through 1602TVC2226O (I, J, K, L, M, N, O); 1602TVU0226I through 1602TVU0226O (I, J, K, L, M, N,O); 1512TVU2029I through 1512TVU2029O (I, J, K, L, M, N,O)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
  • Product Description
    Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. || Product Usage: || The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.
  • Manufacturer
    Parker Medical

Manufacturer

Parker Medical
  • Manufacturer Address
    Parker Medical, 5085 Weeping Willow Cir, Highlands Ranch CO 80130-4485
  • Manufacturer Parent Company (2017)
    RoundTable Healthcare Partners Lp
  • Source
    USFDA