Events

Recall of Cryolife Bioglue Surgical Adhesive

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cryolife Inc.

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
    16856
  • Event Initiated Date
    2014-06-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    At the request of the fda the manufacturer has changed the expiration dating for bioglue surgical adhesive from 24 months to 18 months due to the fact that the serum albumin component monomer failed to meet internally established end of shelf-life specification. the specification limit was set based on manufacturing capability at the time the process was first established.
  • Action
    Instructions for use to be updated

Device

Cryolife Bioglue Surgical Adhesive
  • Model / Serial
    Model: CRY-BG3515-5, Affected: Lot No: all lot numbers pre 14MGV024
  • Manufacturer
    Cryolife Inc

Manufacturer

Cryolife Inc