Events

Recall of Device Recall Ultrasound probe cover, sterile.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by North Coast Medi-Tek 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
    33313
  • Event Risk Class
    Class 2
  • Event Number
    Z-1571-05
  • Event Initiated Date
    2005-06-07
  • Event Date Posted
    2005-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41680
  • 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
    Drape, Surgical - Product Code KKX
  • Reason
    Customer observed unsealed packages.
  • Action
    The recalling firm called their customer and requested the customer to return un-sealed packages.

Device

Device Recall Ultrasound probe cover, sterile.
  • Model / Serial
    Lot number: 0520, expiration date: 1-10.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.
  • Product Description
    Ultrasound probe cover, sterile. Catalog No. 910811.
  • Manufacturer
    North Coast Medi-Tek Inc

Manufacturer

North Coast Medi-Tek Inc
  • Manufacturer Address
    North Coast Medi-Tek Inc, 8603 East Ave, Mentor OH 44060-4366
  • Source
    USFDA