Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Check-Flo Blue Valve Devices, details product brand name (Catalogue identifier[Prefix/Suffix]) as below:
The manufacturer identified an increase in reports of blood loss associated with devices using a specific hemostatic valve design (referred to as the "blue" valve or polyisoprene valve). In November 2015, products manufactured with the hemostatic blue valve design were either obsoleted or changed to incorporate a different valve design with improved hemostasis. The manufacturer has continued to receive reports of blood loss associated with the earlier generation products containing the "blue" valve and therefore has initiated this action on those devices.
According to the manufacturer, potential adverse events that may occur if these devices were used in the arterial system (Flexor Radial Access Sets) include delay in procedure and blood loss. If devices were used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism.
The manufacturer advises users to examine inventory immediately to determine if they have affected products and quarantine affected products. Return the affected products to the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 9 February 2017