Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
FDA Recall #Z-0582-2025 — Class II — October 31, 2024
Product Description
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Reason for Recall
Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
Recalling Firm
Wilson-Cook Medical Inc. — Winston Salem, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
46 devices
Distribution
Distribution was OUS only to Argentina, Brazil, and Israel.
Code Information
UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated