Events

Recall of SUPERSTAT (MODIFIED COLLAGEN HEMOSTAT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUPERSTAT CORPORATION.

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
    144683
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-18
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    This action was taken because previous action hc# 103177 did not notify users that this medical device is unlicensed.

Device

SUPERSTAT (MODIFIED COLLAGEN HEMOSTAT
  • Model / Serial
    Model Catalog: 9200-30 (Lot serial: SSF03); Model Catalog: 9106-00 (Lot serial: SSF03); Model Catalog: 9300-15 (Lot serial: SSN12D); Model Catalog: 9300-15 (Lot serial: SSF03); Model Catalog: 9200-30 (Lot serial: SSN12D); Model Catalog: 9106-00 (Lot serial: SSN12D); Model Catalog: 9300-15 (Lot serial: SSF02); Model Catalog: 9200-30 (Lot serial: SSF02); Model Catalog: 9106-00 (Lot serial: SSF02)
  • Product Description
    Superstat Modified Collagen Hemostat
  • Manufacturer
    SUPERSTAT CORPORATION

Manufacturer

SUPERSTAT CORPORATION
  • Manufacturer Address
    U.S.A.
  • Manufacturer Parent Company (2017)
    Superstat Corp
  • Source
    HC