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Recall Observatory FDA recall evidence

Device product

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

Z-0582-2025

October 31, 2024

Class II

Product summary

Firm
Wilson-Cook Medical Inc.
Event
Event 95755
Status
Ongoing
Classification
Class II
Quantity
46 devices
Official record key
device-enforcement:Z-0582-2025

Official wording

Reason: 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.

Code information: UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.