Wilson-Cook Medical Inc. HEMO-10 Hemospray Endoscopic Hemostat Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.

Recommended Action

Per FDA guidance

Cook Medical notified customers initially via "URGENT: MEDICAL DEVICE RECALL" letters sent on about 02/04/2020 and 02/25/2020. The letters contained the same information and informed customers that Cook Medical has received complaints that the handle and/or activation knob on Hemospray Endoscopic Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Instructions to customers included to examine inventory for affected devices, cease use of them and quarantine them, return affected devices immediately to Cook Medical, and complete and return the Acknowledgement and Receipt Form. Additionally customers were instructed to inform appropriate personnel and customers, if further distributed, of the recall down to the user level. Questions or concerns can be directed to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.