Events

Recall of Device Recall LMA Unique

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LMA North America Inc.

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
    26577
  • Event Risk Class
    Class 2
  • Event Number
    Z-1053-03
  • Event Initiated Date
    2003-06-18
  • Event Date Posted
    2003-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27919
  • 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
    Airway, Oropharyngeal, Anesthesiology - Product Code CAE
  • Reason
    Sterility cannot be assured.
  • Action
    Recall letters were issued on June 18, 2003 to customers. It requests return of product and included a request to fax back inventory description.

Device

Device Recall LMA Unique
  • Model / Serial
    Lots FH041202 and FJ021202
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    LMA- Unique || Laryngeal Mask Airway || Size 4, Catalog No. 12140, Lot FH041202 || Size 4, Catalog No. 12150, Lot FJ021202
  • Manufacturer
    LMA North America Inc

Manufacturer

LMA North America Inc
  • Manufacturer Address
    LMA North America Inc, 9360 Towne Centre Dr, San Diego CA 921213030
  • Source
    USFDA