Angiodynamics, Inc.: Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when

Hazard

Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.

Details from the source

Reason for recall: Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury. Distribution: US Nationwide distribution in the states of AZ, CA, DC, IN, PA. Quantity: 11 units Lot/code info: UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025

UPC codes

15051684018357

Source

Official record: FDA (Device enforcement) ↗

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