Events

Recall of Device Recall Parker Left Double Lumen Endobronchial Tube with Parker FlexTip

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
    76299
  • Event Risk Class
    Class 2
  • Event Number
    Z-1399-2017
  • Event Initiated Date
    2016-12-16
  • Event Date Posted
    2017-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152729
  • 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/bronchial, differential ventilation (w/wo connector) - Product Code CBI
  • Reason
    The product was not functioning as intended. the ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
  • Action
    Parker Medical notified consignees via telephone on December 16, 2016. Consignees were instructed to segregate affected products for immediate pick up. For questions regarding this recall call 239-307-6064.

Device

Device Recall Parker Left Double Lumen Endobronchial Tube with Parker FlexTip
  • Model / Serial
    Lot Numbers: 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, 1605DL0814F
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.
  • Product Description
    Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, || H-PFTDL-41-1. || The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries
  • 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