Events

Safety Alert for CrystalR Metal Disposable Blades (Mac 3 and Mac 4)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Penlon Ltd..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-09-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110923.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Urgent field safety notice: penlon crystalr metal disposable blades (mac 3 and mac 4) medical device manufacturer, penlon ltd., has issued an urgent field safety notice concerning crystalr metal disposable blade (mac 3 and mac 4). penlon has been made aware of an incident where mac 3 blades have been incorrectly packaged in disposable bags labeled as mac 4 and then packed in a carton stating size mac 4. the affected batches have been identified and penlon has determined that this poses a low risk to the users, as users will recognise that the blade is not the size stated on the disposable bag prior to use or during pre-use check. the manufacturer further advised that all theatre staff and stores personnel should check their stock with expiry dates between august 2010 and august 2015 and ensure that the sizes etched on the blades, inner plastic bags, and the carton all match. according to penlon, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

CrystalR Metal Disposable Blades (Mac 3 and Mac 4)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Penlon CrystalR Metal Disposable Blades (Mac 3 and Mac 4)
  • Manufacturer
    Penlon Ltd.

Manufacturer

Penlon Ltd.