Events

Recall of Device Recall SourceOne Healthcare TechnoUltrasound trays.

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
    33314
  • Event Risk Class
    Class 3
  • Event Number
    Z-1572-05
  • Event Initiated Date
    2005-01-18
  • Event Date Posted
    2005-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41684
  • 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
    General Surgery Tray - Product Code LRO
  • Reason
    Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. product is breast biopsy trays, cat. 255826r2. individual tray package labeling correctly identifies the product as breast biopsy tray.
  • Action
    The recalling firm sent corrected labels to the distributor for the labeling of all 5 cases that were on hand.

Device

Device Recall SourceOne Healthcare TechnoUltrasound trays.
  • Model / Serial
    Lot number 0503, expiration date 11-07.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to one customer: Source One Healthcare Technologies distribution center, 4434 Mulhauser Road #300, Hamilton, OH 45011.
  • Product Description
    SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
  • 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