Events

Safety Alert for BioGlue Surgical Adhesive 5mL

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

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
    2014-06-13
  • Event Date Posted
    2014-06-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140613a.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: cryolife bioglue surgical adhesive 5ml medical device manufacturer, cryolife has issued a field safety notice concerning its bioglue surgical adhesive 5ml (product code: bg3515-5). at the request of the united states food and drug administration, the manufacturer has changed the expiration dating for the product from 24 months to 18 months due to the fact that the serum albumin component monomer failed to meet the manufacturer’s internally established end of shelf-life specification. based on the manufacturer’s health risk assessment, serum albumin monomer content below specification does not impose any change in patient risk to the delivered product. the manufacturer has advised users in the united states to either return or re-label the affected products. according to the local supplier, integmed ltd., the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 13 june 2014.

Device

BioGlue Surgical Adhesive 5mL
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: CryoLife BioGlue Surgical Adhesive 5mL
  • Manufacturer
    CryoLife

Manufacturer

CryoLife