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Vascu-Guard Peripheral Vascular Patch (Baxter) – Marketing Brochure Inaccuracy (2023)

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Low

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

Peri-Guard Repair Patch (Baxter) – Marketing Brochure Inaccuracy (2023)

Low

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

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Vascu-Guard Peripheral Vascular Patch (Baxter) – Marketing Brochure Inaccuracy (2023)

Peri-Guard Repair Patch (Baxter) – Marketing Brochure Inaccuracy (2023)

Baxter Coseal Premix (Baxter) – Marketing Brochure Inaccuracy (2023)

Baxter Flo-Rester (Baxter) – Marketing Brochure Inaccuracy (2023)

Trevo Trak 21 Microcatheter (Stryker) – Unapproved Use (2023)

Accure Laser System (Accure) – Laser Energy Misalignment (2023)

Ultrasound EA Table (Oakworks) – Backrest Platform Stress (2023)

Ambu aView 2 A Monitor (Ambu) – Mounting Screw Warning (2023)

CYF-5 Cystonephrofiberscope (Olympus) – Cleaning Brush Update (2023)

Soltive Laser Fibers (Olympus) – Sterile Pouch Seal (2023)

ENF-XP Rhino-Laryngofiberscope (Olympus) – Cleaning Brush Update (2023)

CYF-VHR Videoscope (Olympus) – Cleaning Brush Update (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

CYF-V2R Visera Videoscope (Olympus) – Cleaning Brush Update (2023)

Dover Hydrogel Foley Tray (Cardinal Health) – Recalled Component (2023)

Trach Kit (Cardinal Health) – Recalled Component (2023)

CYF-5R Cystonephrofiberscope (Olympus) – Cleaning Brush Update (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

Argyle Suction Catheter Tray (Cardinal Health) – Recalled Component (2023)