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.
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: US Nationwide - Worldwide Distribution Quantity: 63,830 units Lot/code info: UDI/DI : a) 00827002565722, b) 00827002246638; All unexpired lot numbers
00827002565722, 00827002246638
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.