Events

Recall of Device Recall PleuraGuide Kit

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
    65678
  • Event Risk Class
    Class 2
  • Event Number
    Z-1987-2013
  • Event Initiated Date
    2013-07-16
  • Event Date Posted
    2013-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119863
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Reason
    Individual component's ifus are not included with the kit.
  • Action
    Notice of correction was sent on July 18, 2013 via UPS and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. It provides instructions how to handle the product that may be affected. Additional labeling will be added to the kit to include instructions for use for the additional components. Atrium Medical will confirm through tracking of the UPS letters that each consignee has received the letter of correction. This shall be 100%. Where a UPS delivery cannot be confirmed, Atrium Medical will make good faith effort to contact the consignee to ensure that the letter was received.

Device

Device Recall PleuraGuide Kit
  • Model / Serial
    Part Number: 17100: 10734588, 10734583, 10728237, 10728236, 10728235, 10728234, 10736244, 10736243, 10736242, 10736238, 10734590, 10734589, 10736245, 10852352, 10847222, 10847218, 10842301, 10842299, 10842297, 10840114, 10834292, 10829188, 10852337, 10852334, 10834291, 10834286, 10834284, 10860795, 10857119, 10857111, 10864592, 10864104, 10856867, 10875059, 10875046 , 10871063, 10871059, 10868989, 10879191, 10879190, 10889037, 10887634, 10887292, 10884093, 10879192, 10891329, 10884084;Part Number: 17150: 10728238, 10734584, 10823084, 10800926, 10827874, 10827874, 10834299, 10857110, 10881097, 10874228, 10867130; Part Number 17200: 10728239, 10734585, 10794372, 10802727, 10802725, 10820803, 10825183, 10834338, 10852339, 10864105, 10884087
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. || Indicated to assist with the insertion of thoracic catheters.
  • 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