Events

Recall of LAERDAL COMPACT SUCTION UNIT 4 (LCSU 4)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LAERDAL MEDICAL AS.

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
    22954
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-07
  • 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
    The on/off functionality in the lcsu 4 is controlled by electronic components. one of these components might be damaged. the damage occurs over time when the unit is connected to a power source (battery or external power source) but is not related to frequency of use. a damaged component will result in failure of the on/off functionality: the lcsu 4 cannot be turned off and it may turn on by itself.

Device

LAERDAL COMPACT SUCTION UNIT 4 (LCSU 4)
  • Model / Serial
    Model Catalog: 88006101 (Lot serial: 150505A0836 TO 160901A0226); Model Catalog: 88005101 (Lot serial: 150505A0836 TO 160901A0226); Model Catalog: 88005201 (Lot serial: 150505A0836 TO 160901A0226); Model Catalog: 88006201 (Lot serial: 150505A0836 TO 160901A0226)
  • Product Description
    LAERDAL COMPACT SUCTION UNIT 4 (LCSU 4)
  • Manufacturer
    LAERDAL MEDICAL AS

Manufacturer

LAERDAL MEDICAL AS
  • Manufacturer Address
    STAVANGER
  • Manufacturer Parent Company (2017)
    Laerdal Invest AS
  • Source
    HC