Boston Scientific Corporation: ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000

Hazard

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Details from the source

Reason for recall: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. Distribution: Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.) Quantity: 18 units Lot/code info: FPRCH8000 UDI-DI: 00859019006370, Serial Numbers: ICP0305, ICP0369, ICP0338; FPRCH8000-02 UDI-DI: 00859019006417, Serial Numbers: 86643865, 108415728, 88589050, 108470986, 89392275, 108612524, 107799735, ICP0299, 107887794, 3779, 108254011, IF0096 108312221, 104733618; H749396118000 UDI-DI: 00191506014995, Serial Numbers: 106066356, 107851990

UPC codes

00859019006370, 00859019006417, 00191506014995

Source

Official record: FDA (Device enforcement) ↗

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