Events

Recall of Device Recall Applied Medical Kii Optical Access System

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

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
    52774
  • Event Risk Class
    Class 2
  • Event Number
    Z-2226-2009
  • Event Initiated Date
    2009-06-04
  • Event Date Posted
    2009-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83977
  • 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 - Product Code GCJ
  • Reason
    Applied medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm kii non-threaded optical access system, model c0r36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.
  • Action
    Applied Medical Resources Corp. notified Customers via an overnight "Voluntary Recall Notification" Letter dated June 9, 2009. The letter informed customers of the reason for recall and asked that the listed product be returned. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).

Device

Device Recall Applied Medical Kii Optical Access System
  • Model / Serial
    Model Number: C0R36, Lot Numbers:1084426 and 1085506.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide -- United States, Australia, New Zealand, France, Canada, Norway and Great Britain.
  • Product Description
    Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. || Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Manufacturer Address
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Manufacturer Parent Company (2017)
    Applied Medical Corporation
  • Source
    USFDA