Datascope Corp.: Cardiosave Rescue

Hazard

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Details from the source

Reason for recall: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. Distribution: Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Es Quantity: 47 units (44 US, 3 OUS) Lot/code info: Model: 0998-00-0800-83; UDI-DI: 10607567108407; Serial Numbers: All;

UPC codes

10607567108407

Source

Official record: FDA (Device enforcement) ↗

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