Z-1979-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2023
- Initiation Date
- May 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,877 units
Product Description
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
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.
Distribution Pattern
US Nationwide - Worldwide Distribution
Code Information
UDI/DI : a) 00827002210493, b) 00827002213463; All unexpired lot numbers