FDAFDA · Food and drugs·Recall number Z-0582-2025
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Published December 11, 2024 · Recall initiated: October 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wilson-Cook Medical Inc.
- Distributor
- Distribution was OUS only to Argentina, Brazil, and Israel.
- Lot
- UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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