Events

Safety Alert for Check-Flo Blue Valve Devices

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cook Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-02-09
  • Event Date Posted
    2017-02-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170209.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: cook medical check-flo blue valve devices 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: check-flo hemostasis assembly ( cfm-200) flexor radial access set ( kcfn-4.0(5.0, 6.0, 7.0)- / -ra-(s)-hc) triforce peripheral crossing set ( kcxs-5.0- / -rb-0/0-hc, kcxs-5.0- / -rb-0/dav-hc, kcxs-5.0- / -rb-mpb/0-hc, kcxs-5.0- / -rb-mpb/dav-hc) check-flo performer introducer set ( rcf-4.0(5.0, 6.0, 7.0, 8.0)- / -bv check-flo performer introducer ( rcfw-4.0(5.0, 6.0, 7.0, 8.0)- / -bv micropuncture check-flo performer introducer set ( rcfn-4.0(5.0, 6.0, 7.0)- / -mpis-nt-bv check-flo introducer hausdorf-lock atrial ( rcfw-7.0(8.0)-38-75-rb-hla-091100-bv 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.

Device

Check-Flo Blue Valve Devices
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cook Medical Check-Flo Blue Valve Devices
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical