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).
Reason for recall: 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). Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong. Quantity: 82020 units Lot/code info: 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-Thru Intraluminal Shunt: ALL SERIAL NUMBERS: a) 7081015, UDI/DI00085412532554; b) 7081015ES, UDI/DI00085412532646; c) 7081520, UDI/DI00085412532561; d) 7081520ES, UDI/DI00085412532653; e) 7082025, UDI/DI00085412532578; f) 7082025ES, UDI/DI00085412532660; g) 7151015, UDI/DI00085412532585; h) 7151015ES, UDI/DI00085412532677; i) 7151520, UDI/DI00085412531908; j) 7151520ES, UDI/DI00085412531915; k) 7152025, UDI/DI00085412531922; l) 7152025ES, UDI/DI00085412531939; m) 7451015, UDI/DI00085412531946; n) 7451015ES, UDI/DI00085412531953; o) 7451520, UDI/DI00085412531960; p) 7451520ES, UDI/DI00085412531977; q) 7452025, UDI/DI00085412531984; r) 7452025ES, UDI/DI00085412531991
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.