Class II

Medical Device Recall: Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

Wilson-Cook Medical Inc. · October 31, 2024

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.

Distribution

Distribution was OUS only to Argentina, Brazil, and Israel.

Quantity Affected

46 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0582-2025

Status: ongoing

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