FDAFDA · Food and drugs·Recall number Z-1524-2024
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: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES
Published April 24, 2024 · Recall initiated: February 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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