Wilson-Cook Medical Inc. recalls Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
- Recall date
- October 31, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0582-2025
- FDA classification
- Class II
- Brand / firm
- Wilson-Cook Medical Inc.
- Sold / distributed
- Distribution was OUS only to Argentina, Brazil, and Israel.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
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