Recall Z-1979-2023 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Wilson-Cook Medical Inc.
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
| Date | Jun 21, 2023 (initiated May 22, 2023) |
| Status | Open, Classified |
| Reason | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope. |
| Root cause | Under Investigation by firm |
| Action | The firm notified their consignees by letter and email beginning on 05/22/2023. The notice explained the issue, risk, and requested the following: Complete and return the Acknowledgement Form, ensure the notification is shared with appropriate personnel, down to the user level or customers if devices were further distributed, report any adverse events. |
| Quantity | 14,877 units |
| Distribution | US Nationwide - Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200972 | Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc., Jun 10, 2020 |