Z-1522-2024 Class II Ongoing

Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS

The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).

Cardiovascular Specialty marketing brochures: Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version Flo-Rester: ALL SERIAL NUMBERS: a) 50100, UDI/DI 00085412532592; b) 50125, UDI/DI 00085412532684; c) 50150, UDI/DI 00085412532608; d) 50175, UDI/DI 00085412532691; e) 50200, UDI/DI 00085412532431; f) 50225, UDI/DI 00085412532448; g) 50250, UDI/DI 00085412532455; h) 50275, UDI/DI 00085412532462; i) 50300, UDI/DI 00085412532479; j) 50350, UDI/DI 00085412532486; k) 50400, UDI/DI 00085412532493; l) 50450BIOS, UDI/DI 00085412532509; m) 60100, UDI/DI 00085412532516; n) 60125BIOS, UDI/DI 00085412532110; o) 60150BIOS, UDI/DI 00085412532127; p) 60175, UDI/DI 00085412532134; q) 60200BIOS, UDI/DI 00085412532141; r) 60225BIOS, UDI/DI 00085412532158; s) 60250BIOS, UDI/DI 00085412532523; t) 60275, UDI/DI 00085412532615; u) 60300, UDI/DI 00085412532530; v) 60350, UDI/DI 00085412532622; w) 60400BIOS, UDI/DI 00085412532547; x) 60450BIOS, UDI/DI 00085412532639