Recall Z-1745-2020 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Wilson-Cook Medical Inc.
HEMO-7 Hemospray Endoscopic Hemostat
| Date | Feb 4, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 immedia |
| Quantity | 89,423 devices total |
| Distribution | Nationwide distribution. International distribution to Bahrain, Belarus, Canary Islands, Gibraltar, Guadeloupe, Guernsey, Iraq, Israel, Jersey, Jordan, Kuwait, Lebanon, Martinique, Monaco, Morocco, Oman, Pakistan, Qatar, Reunion, Saudi Arabia, Tunisia, United Arab Emirates, Unites States, Canada, N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.