Integra LifeSciences Corp. (NeuroSciences): Extended Tip Applicator, 8CM, Box of 5.

Hazard

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

Details from the source

Reason for recall: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. Distribution: Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Quantity: 6,216 units Lot/code info: Model/Catalog Number: 205108; UDI: 10381780000143; All Lots.

UPC codes

10381780000143

Source

Official record: FDA (Device enforcement) ↗

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