Events

Recall of Device Recall BioGlue

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    77369
  • Event Risk Class
    Class 2
  • Event Number
    Z-2623-2017
  • Event Initiated Date
    2017-05-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155852
  • 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
    Glue,surgical,arteries - Product Code MUQ
  • Reason
    The courtesy labels in 9 boxes of bioglue were incorrectly labeled as lot 17mjx007 instead of lot 17mjx002.
  • Action
    Firm notified customer on approximately 06/02/2017 via letter. Instructions included to inspect inventory on hand, to destroy the incorrect courtesy labels and replace them with the correct labels what were shipped.

Device

Device Recall BioGlue
  • Model / Serial
    Lot Code 17MJX002, Model/Catalog Number BG3510-5-J
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Product distributed in Japan.
  • Product Description
    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
  • Manufacturer
    CryoLife, Inc.

Manufacturer

CryoLife, Inc.
  • Manufacturer Address
    CryoLife, Inc., 1655 Roberts Blvd NW, Kennesaw GA 30144-3632
  • Manufacturer Parent Company (2017)
    Cryolife Inc.
  • Source
    USFDA