Events

Recall of OASIS CHEST DRAIN

According to Health Canada (via FOI), this recall involved a device in Canada 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
    68508
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    To provide clarification about the packaging configuration of the products. products are packaged with a double sequential sterile wrap and placed into an outer dust cover. the dust cover is secured with the package label. the label on the outer package denotes the product as being sterile. the chest drain inside the packaging is sterile but the outer dust cover is not sterile.

Device

OASIS CHEST DRAIN
  • Model / Serial
    Model Catalog: 3600-100 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2012-320 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2002-400 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2002-300 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2002-000 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 4020-100N (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 4000-100N (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 16400 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 3612-400 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 3650-100 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 3620-100 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 3612-100 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2050-000 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2002-100 (Lot serial: Lots expiring before Oct. 2019)
  • Product Description
    Oasis Chest Drain;Ocean Chest Drain;Express Chest Drain;Express Mini 500 Chest Drain
  • Manufacturer
    ATRIUM MEDICAL CORPORATION

Manufacturer

ATRIUM MEDICAL CORPORATION
  • Manufacturer Address
    HUDSON
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC