Events

Recall of Jackson Improved Short Stainless Steel Tracheostomy Tubes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Premier Dental Products Co.

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
    29920
  • Event Risk Class
    Class 2
  • Event Number
    Z-1462-04
  • Event Initiated Date
    2004-08-05
  • Event Date Posted
    2004-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34775
  • 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 Tracheostomy And Tube Cuff - Product Code JOH
  • Reason
    Foreign objects (polishing stones) in the tubes.
  • Action
    The recalling firm issued a recall letter dated 8/5/04 to their distributors. The letter informs the accounts of the problem and the need to return any affected product. The recalling firm issued a second letter dated 8/11/04 to the distributors with instructions to conduct a sub-recall.

Device

Jackson Improved Short Stainless Steel Tracheostomy Tubes
  • Model / Serial
    all lots ending with S or T
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to 45 distributors nationwide. The products were also shipped to Canada, Malaysia, Taiwan, Thailand, Turkey, and the Dominican Republic.
  • Product Description
    Tracheostomy Tubes, Jackson Improved Short Stainless Steel, item number 1034930 size 00, item number 1034940 size 0, item number 1034941 size 1, item number 1034942 size 2, item number 1034943 size 3, item number 1034944 size 4, item number 1034945 size 5, item number 1034946 size 6, item number 1034947 size 7, item number 1034948 size 8, item number 1034949 size 9, and item number 1034950 size 10.
  • Manufacturer
    Premier Dental Products Co

Manufacturer

Premier Dental Products Co
  • Manufacturer Address
    Premier Dental Products Co, 1710 Romano Dr, Plymouth Meeting PA 19462-2822
  • Source
    USFDA