Events

Recall of Device Recall Crystal Metal Miller Disposable Blades

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

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
    58820
  • Event Risk Class
    Class 2
  • Event Number
    Z-3213-2011
  • Event Initiated Date
    2011-03-10
  • Event Date Posted
    2011-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100372
  • 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
    Penlon Ltd ( frmly East Healthcare ) sent an " Urgent Field Safety Notice" dated March 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to check their stock with expiry dates between August 2010 to July 2015, and ensure that the sizes written on the blades, inner plastic bags, and the carton all match. Please complete the reply form below and send to the address provided. If you have any stock where the sizes on the bags, blades, and carton do not match, quarantine the blades and contact Penlon using the information below. For further questions please call 44 1235 547093.

Device

Device Recall Crystal Metal Miller Disposable Blades
  • Model / Serial
    All lots with expiration dates between August 2010 and July 2015
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of CA, VA and WI., and the countries of Belgium, Ireland, France, Netherlands, Norway, Portugal, Switzerland, UK, Hong Kong, Greece, Bahrain and China.
  • Product Description
    Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 || Disposable laryngoscope blades
  • Manufacturer
    Penlon, Ltd. (Fmly East Healthcare)

Manufacturer

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