Events

Recall of John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gf Health Products, 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
    53301
  • Event Risk Class
    Class 2
  • Event Number
    Z-0139-2010
  • Event Initiated Date
    2009-09-14
  • Event Date Posted
    2009-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85240
  • 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
    tracheostomy tube - Product Code BTO
  • Reason
    Incorrect material. manufacturer changed the material of the trach tube from stainless steel to german silver/nickel, contrary to product specifications.
  • Action
    GF Health Products (Graham Field) notified consignees by certified US Mail on/about 09/14/2009. The distribution to the dealers includes the announcement of the recall to the dealer the letter to send to the end users and a Proof of Compliance card for the dealer to submit to Graham Field following completion of the recall instructions. Graham-Field instructed the dealers to return any impacted products on site, as well as any delivered by end-users, customers or other impacted third parties. Dealer will be compensated for executing the recall. Graham Field does not have direct access to end user names; however it plans to reach end-users by financially supporting a mailing from dealers to their individual customers notifying them of this recall. A follow up 60 day certified mailing will be performed for non-responders. The dealers will receive financial support for this second mailing. A secure third company will be contracted to hold for destruction all products affected by this recall. The method of destruction will be to cut the products into pieces, make them not usable. The FDA will be notified prior to the destruction of product and detailed logs and records will be maintained. Periodic effectiveness status report will be maintained for this recall.

Device

John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube
  • Model / Serial
    Codes: Stock Code: 1#4, 3x 8mm, PO Number: 010707, 011512, 017479, 025991, 027823, 028364 and 029447; Stock Code: 1#5, 3 3/8 x 9mm, PO Number: 010707, 011512, 024048, 025151, 028364, 029447, 031261 and 034276; Stock Code: 1#7, 4 x 11 mm, PO Number: 011512, 020608, 023244, 031261, 033471 and 034276; Stock Code: 1#8, 4 ¿ x 12 mm, PO Number: 011512, 017756, 023244, 027339 and 033252; Stock Code: 1#9, 4 3/8 x 13 mm, PO Number: 011512 and 012479 and Stock Code: 1#10, PO Number: 010707 and 011512.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.
  • Manufacturer
    Gf Health Products, Inc.

Manufacturer

Gf Health Products, Inc.
  • Manufacturer Address
    Gf Health Products, Inc., 2935 Northeast Pkwy, Atlanta GA 30360
  • Manufacturer Parent Company (2017)
    GF Health Products Inc.
  • Source
    USFDA