Events

Field Safety Notices about Check-Flo hemostasis assembly and others

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Cook Medical Europe.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-02-06
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Cook medical begins the process of voluntarily recalling the above products and batch numbers. we have seen an increase in reports of blood loss related to devices whose design includes a special hemostatic valve (also called a "blue" valve or polyisoprene valve). in november 2015, products with blue haemostatic valves were either discontinued or replaced with products containing a different valve design with improved hemostasis. cook continued to receive reports of blood loss related to the previous generation of products with "blue" valves and therefore initiated the procedure described above in connection with these products.

Device

Check-Flo hemostasis assembly and others
  • Model / Serial
    KCFN-4.0-18-13-RA-HC G35597 KCFN-4.0-18-23-RA-HC G35598 KCFN-4.0-18-7-RA-HC G35596 KCFN-5.0-18-13-RA-HC G35600 KCFN-5.0-18-13-RA-S-HC G35607 KCFN-5.0-18-23-RA-HC G35601 KCFN-5.0-18-7-RA-HC G35599 KCFN-6.0-18-13-RA-HC G35603 KCFN-6.0-18-13-RA-S-HC G35608 KCFN-6.0-18-23-RA-HC G35604 KCFN-6.0-18-23-RA-S-HC G35609 KCFN-6.0-18-7-RA-HC G35602 KCFN-7.0-18-13-RA-HC G35605 KCFN-7.0-18-23-RA-HC G35606 Komplet TriForce™ za periferni prehod KCXS-5.0-35-100-RB-0/0-HC G56416 KCXS-5.0-35-65-RB-0/0-HC G56412 KCXS-5.0-35-65-RB-0/DAV-HC G56413 KCXS-5.0-35-65-RB-MPB/DAV-HC G56415 Pripomoček za uvajanje Check- Flo ® Hausdorf-Lock atrijski RCFW-7.0-38-75-RB-HLA-091100- BV G03769 RCFW-8.0-38-75-RB-HLA-091100- BV G03770
  • Manufacturer
    Cook Medical Europe

Manufacturer

Cook Medical Europe