FDA recall Z-1979-2023

Product

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

US Nationwide - Worldwide Distribution

Key facts

Status

Ongoing

Initiation date

2023-05-22

Report date

2023-06-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winston Salem, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1979-2023