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

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.

Details from the source

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: 46 devices Lot/code info: UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.

UPC codes

00827002246638

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.