Events

Recall of Device Recall TrachEze Closed Suction System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorenson Medical, 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
    25200
  • Event Risk Class
    Class 2
  • Event Number
    Z-0496-03
  • Event Initiated Date
    2002-11-25
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25371
  • 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
    Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.
  • Action
    On 10/25/2002, all consignees were notified by letter.

Device

Device Recall TrachEze Closed Suction System
  • Model / Serial
    Product Code #220070, Lots 206082 and 206106.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy.
  • Product Description
    Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.
  • Manufacturer
    Sorenson Medical, Inc.

Manufacturer

Sorenson Medical, Inc.
  • Manufacturer Address
    Sorenson Medical, Inc., 1375 West 8040 South, West Jordan UT 84107-2649
  • Source
    USFDA