Events

Recall of Device Recall Auto Suture

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

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
    35491
  • Event Risk Class
    Class 2
  • Event Number
    Z-1152-06
  • Event Initiated Date
    2006-05-22
  • Event Date Posted
    2006-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46259
  • 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
    venous access system - Product Code FOZ
  • Reason
    The 9f device may contain a 10 f sheath instead of the 9f.
  • Action
    United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.

Device

Device Recall Auto Suture
  • Model / Serial
    Lot Number:  N5M255
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and International Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec
  • Product Description
    Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath || Catalog Number: 120049
  • Manufacturer
    United States Surgical

Manufacturer

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