Events

Recall of Crystal Metal Disposable Blades

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Penlon, Ltd..

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
    59992
  • Event Risk Class
    Class 2
  • Event Number
    Z-1221-2012
  • Event Initiated Date
    2011-09-21
  • Event Date Posted
    2012-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104185
  • 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
    Laryngoscope, rigid - Product Code CCW
  • Reason
    Disposable laryngoscope blades incorrectly labeled with wrong size.
  • Action
    InterMed Penlon sent and Urgent Field Safety Notice letter dated September 21, 2011 to affected customers. The letter identified the affected product, problem and advice on actions to be taken by user. Customers were instructed to complete the Reply Form and send to the address provided.

Device

Crystal Metal Disposable Blades
  • Model / Serial
    All lots with expiration dates between August 2011 and August 2016.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the countries of Belgium, France, Greece, Ireland, Italy, Lithuania, Netherlands, Norway, Portugal, Switzerland, Canada, China, Hong Kong and Malaysia.
  • Product Description
    Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) || Product Usage: Disposable laryngoscope blades.
  • Manufacturer
    Penlon, Ltd.

Manufacturer

Penlon, Ltd.
  • Manufacturer Address
    Penlon, Ltd., Abingdon Science Park, Barton Lane, Abingdon United Kingdom
  • Manufacturer Parent Company (2017)
    BPL Medical Technologies Pvt Ltd.
  • Source
    USFDA