Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Fast-Cath Trio Hemostasis Introducer. The affected product is identified as follows:
The manufacturer is voluntarily recalling one lot of the Fast-Cath Trio Hemostasis Introducer. As a result of a manufacturing error, this affected lot contained 12F sized dilators and sheaths instead of the expected 14F devices. If an affected device is used during a procedure, resistance may be encountered during insertion of the selected catheter. This would require replacement of the device prior to proceeding.
According to the manufacturer, the risk of patient harm is low and is limited to risks associated with a delay in procedure. All other lots of model and any of the other models of the Fast-Cath Trio Hemostasis Introducer are not impacted and can be used. There have been seven customer reports of non-conforming devices, none of which were associated with patient impact.
The affected users are advised to take the following actions:
According to the local supplier, the affected lot is not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 12 December 2019