Events

Recall of Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vanguard Medical Concepts, 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
    35506
  • Event Risk Class
    Class 2
  • Event Number
    Z-1212-06
  • Event Initiated Date
    2006-03-17
  • Event Date Posted
    2006-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46279
  • 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
    Laparoscope, General & Plastic Surgery, Reprocessed - Product Code NLM
  • Reason
    Review of complaints and testing show that the distal tip of the trocars may separate while in use.
  • Action
    The firm sent recall notification letters to its consignees on 3-17-2006. They were instructed to discontinue use of the 35NLT, 35NST and 35Ol Reprocessed Optiview Trocars with expiration date of 12/20008 or earlier immediately. Any of this product in inventory were to be returned to the manufacturer for credit. The firm also offered the assistance of its representatives in returning all affected profucts. The investigation is ongoing, and corrective actions associated with the root cause of tips breaking off have been identified and are being implemented.

Device

Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
  • Model / Serial
    All lot numbers produced before January, 1, 2006. (Product with expiration date of 12/20008 or earlier.)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
  • Manufacturer
    Vanguard Medical Concepts, Inc

Manufacturer

Vanguard Medical Concepts, Inc
  • Manufacturer Address
    Vanguard Medical Concepts, Inc, 5307 Great Oak Dr, Lakeland FL 33815
  • Source
    USFDA