Events

Recall of AutoSuture

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ascent Healthcare Solutions, 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
    37162
  • Event Risk Class
    Class 2
  • Event Number
    Z-0414-2007
  • Event Initiated Date
    2006-10-19
  • Event Date Posted
    2007-02-08
  • 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=50019
  • 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
    Endoscopic Trocar - Product Code NLM
  • Reason
    The tip of the trocars may separate before and while in use. in some instances the trocars have been found with exposed blades upon opening the packaging.
  • Action
    The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form.

Device

AutoSuture
  • Model / Serial
    94724 95261 104057 94853 95272 104217 94893 100062 104335 94894 102389 104337 94897 102394 104343 94953 102681 104584 94957 102851 105517 94962 103100  94964 103103  95024 103200  95026 103288  95029 103293  95069 103297  95135 103566  95259 103570
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.
  • Manufacturer
    Ascent Healthcare Solutions, Inc.

Manufacturer

Ascent Healthcare Solutions, Inc.
  • Manufacturer Address
    Ascent Healthcare Solutions, Inc., 5307 Great Oak Dr, Lakeland FL 33815
  • Source
    USFDA