Recall Z-1746-2020— Wilson-Cook Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2020-02-04, terminated 2021-01-15. FDA's recall record names no specific 510(k) clearance for this event. Product: HEMO-10 Hemospray Endoscopic Hemostat. 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..
- Recalling firm
- Wilson-Cook Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-04
- Terminated
- 2021-01-15
- Firm location
- Winston Salem, NC, United States
Product description
HEMO-10 Hemospray Endoscopic Hemostat
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.