Events

Recall of COSEAL SURGICAL SEALANT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER 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
    131463
  • Event Risk Class
    III
  • Event Initiated Date
    2011-08-03
  • 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
    The recall is being conducted as a precautionary measure due to out of specification (oos) results observed at the 24 month time point (out of 24-month licensed shelf life to expiration) during a coseal stability study. the parameter that is oos is an indicator of possible failure for the product to gel appropriately. all other stability requirements were met.

Device

COSEAL SURGICAL SEALANT
  • Model / Serial
    Model Catalog: 934071 (Lot serial: HA090944); Model Catalog: 934071 (Lot serial: HA090950)
  • Product Description
    COSEAL SURGICAL SEALANT
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION