Events

Recall of Atrium Express Dry Seal Chest Drain ATS Blood Recovery

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
    68398
  • Event Risk Class
    Class 2
  • Event Number
    Z-1959-2014
  • Event Initiated Date
    2014-04-28
  • Event Date Posted
    2014-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127513
  • 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
    Apparatus, autotransfusion - Product Code CAC
  • Reason
    Product that was previously recalled because the chest drain tubing of the ats blood recovery may leak or disconnect, was released for distribution in error.
  • Action
    Smith & Nephew notified Distributors on April 28, 2014 by telephone. A follow up e-mail and a recall notification letter were issued by UPS on 6/27/14. Distributors were requested to notify customers who received the lot. A reply acknowledgement form was to be completed and returned. Return Goods Authorizations for the return of the goods were issued to customers.

Device

Atrium Express Dry Seal Chest Drain ATS Blood Recovery
  • Model / Serial
    Lot Number: 10906458
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
  • Product Description
    Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. || Autotransfusion Apparatus.
  • 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