Events

Recall of Device Recall Atrium

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Atrium Medical 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
    36925
  • Event Risk Class
    Class 2
  • Event Number
    Z-0500-2007
  • Event Initiated Date
    2006-11-08
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49575
  • 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
    chest drain - Product Code CAC
  • Reason
    Chest drainage tubing incorrectly assembled and may disconnect from patient during use.
  • Action
    Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.

Device

Device Recall Atrium
  • Model / Serial
    Lot Numbers; 10137320, 10116878, 10101974
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including CA, and PA.
  • Product Description
    Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package || Model Number: 4050-170N
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Address
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA