Events

Recall of Device Recall AutoSuture

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

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
    32569
  • Event Risk Class
    Class 2
  • Event Number
    Z-1092-05
  • Event Initiated Date
    2005-06-30
  • Event Date Posted
    2005-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40350
  • 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
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Reason
    The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use.
  • Action
    United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.

Device

Device Recall AutoSuture
  • Model / Serial
    Lot Numbers: N4G435 N4J328 N4K344 N5A181
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
  • Product Description
    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit || Catalog Number: 120021
  • Manufacturer
    United States Surgical Corporation

Manufacturer

United States Surgical Corporation
  • Manufacturer Address
    United States Surgical Corporation, 195 Mcdermott Rd, North Haven CT 06473-3665
  • Source
    USFDA