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
    48124
  • Event Risk Class
    Class 2
  • Event Number
    Z-1852-2008
  • Event Initiated Date
    2008-05-12
  • Event Date Posted
    2008-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70885
  • 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
    Thoracic Catheter - Product Code GBZ
  • Reason
    Heparin-coated thoracic catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate.
  • Action
    Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice.

Device

Device Recall Atrium
  • Model / Serial
    Lot #s 10307011, 10311261, 10318740, 10327154, 10336322, 10336532
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
  • Product Description
    HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets, Increased Length by 6", || Atrium Code # 14720, || Size 20, || # Eyelets 15, || 10 per case
  • 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