Events

Recall of Device Recall APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Laerdal 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
    79190
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-2018
  • Event Initiated Date
    2017-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161566
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Reason
    A shipment of lcsu 4 suction units and canisters attempted importation into the united states but was refused by fda for lack of necessary approvals with cdrh by the foreign firms.
  • Action
    On September 5, 2017, a letter was mailed to customers notifying them that they received one of the units subject to recall. The letter requested that the customer return the affected item for a replacement. Questions or concerns can be directed to 1-877-523-7325 or email: customerservice@laerdal.com , referencing the following number: 2017-R-05.

Device

Device Recall APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED
  • Model / Serial
    Affected SNs between: 170401A0001 and 170401A0270
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    LCSU 4, Laerdal Compact Suction Unit || The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
  • Manufacturer
    Laerdal Medical Corporation

Manufacturer

Laerdal Medical Corporation
  • Manufacturer Address
    Laerdal Medical Corporation, PO Box 1840, 167 Myers Corners Rd, Wappingers Falls NY 12590-3869
  • Manufacturer Parent Company (2017)
    Laerdal Medical Corporation
  • Source
    USFDA