Z-0582-2025 Class II Ongoing
FDA device recall Z-0582-2025 was initiated by Wilson-Cook Medical Inc. on October 31, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 46 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 31, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 devices
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.
Distribution Pattern
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.