Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
FDA device recall Z-1978-2023 · posted 2023-06-21 · Open, Classified
Recall details
- Recalling firm
- Wilson-Cook Medical Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- QAU
- Quantity affected
- 63,830 units
- Distribution
- US Nationwide - Worldwide Distribution
- Date initiated
- 2023-05-22
- Date posted
- 2023-06-21
- Location
- Winston Salem, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Hemospray Endoscopic Hemostat (K200972) | Wilson-Cook Medical, Inc. | 2020-06-10 |