Events

Safety Alert for Teleflex Medical CAPIO Sutures

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific / Teleflex Medical.

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
    2014-03-19
  • Event Date Posted
    2014-03-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140319b.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
    Medical device safety alert: boston scientific teleflex medical capio sutures medical device distributor, boston scientific, has issued a medical device safety alert concerning teleflex medical capio sutures at the request of the manufacturer, teleflex medical. the catalogue numbers of the affected products include: 833-114, 833-123, 833-124, 833-136, 833-137, 833-213. according to the manufacturer, certain lots of the products did not meet minimum needle attachment strength, knot tensile strength, minimum diameter, or minimum resorption strength requirements. this may result in suture breakage, delay in procedure, wound dehiscence, or the need of additional surgical intervention. the manufacturer will recall all affected products. according to the local supplier, the affected products were not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 march 2014.

Device

Teleflex Medical CAPIO Sutures

Manufacturer

Boston Scientific / Teleflex Medical