Events

Recall of Device Recall Atrium 36Fr Right Angled Firm PVC Thoracic Catheter

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
    71510
  • Event Risk Class
    Class 2
  • Event Number
    Z-2346-2015
  • Event Initiated Date
    2015-06-19
  • Event Date Posted
    2015-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138023
  • 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
    Catheter, cholangiography - Product Code GBZ
  • Reason
    Inner pouches incorrectly labeled as part 8136, 36fr right angled thermosensitive pvc catheter, but are part 15236-36fr right angled firm pvc catheter.
  • Action
    Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).

Device

Device Recall Atrium 36Fr Right Angled Firm PVC Thoracic Catheter
  • Model / Serial
    Lot Number : ME215673 EXp: 2019/09
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AZ, CA, LA. IN, NC, TN, TX, VA
  • Product Description
    Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) || Part Number: 15236
  • 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