Events

Recall of Device Recall 15mm Separator 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
    49445
  • Event Risk Class
    Class 2
  • Event Number
    Z-0024-2009
  • Event Initiated Date
    2008-06-25
  • Event Date Posted
    2008-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73339
  • 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
    laparoscopic trocar - Product Code HET
  • Reason
    Potential inability to insufflate through the stopcock. under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (c02).
  • Action
    Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided.

Device

Device Recall 15mm Separator Access System
  • Model / Serial
    Product/Kit Batch Numbers: 1061115, 1058102, 1057096
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada distribution.
  • Product Description
    Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

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