FDA recall Z-0132-2023

Angiodynamics, Inc. · Class II · device

Product

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 patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling UPN: H787MPP5SAT0 Catalog Number: MP-P5SAT

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.

Key facts

Status: Ongoing
Initiation date: 2022-09-20
Report date: 2022-11-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0132-2023