Events

Recall of Premie Pack

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

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
    53550
  • Event Risk Class
    Class 1
  • Event Number
    Z-0105-2010
  • Event Initiated Date
    2009-09-22
  • Event Date Posted
    2009-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85826
  • 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
    Tracheal tube - Product Code BTR
  • Reason
    The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.
  • Action
    The firm's sales representative was notified of the recall on September 22, 2009 via email and the sole customer was notified by letter dated September 23, 2009. All product was removed from the customer account on September 28, 2009 and returned to the recalling firm.

Device

Premie Pack
  • Model / Serial
    Lots 901087, 903267, 907307, 910297, 901218, 908258, 2009020990 and 2009022390.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Illinois.
  • Product Description
    Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. || Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes.
  • Manufacturer
    Centurion Medical Products

Manufacturer

Centurion Medical Products
  • Manufacturer Address
    Centurion Medical Products, 301 Catrell Dr, Howell MI 48843-1703
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA