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Recall Observatory FDA recall evidence

Device product

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

Z-1979-2023

May 22, 2023

Class II

Product summary

Firm
Wilson-Cook Medical Inc.
Event
Event 92345
Status
Ongoing
Classification
Class II
Quantity
14,877 units
Official record key
device-enforcement:Z-1979-2023

Official wording

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.

Code information: UDI/DI : a) 00827002210493, b) 00827002213463; All unexpired lot numbers

Distribution pattern: US Nationwide - Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.