BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0132-2023 · Initiated September 20, 2022

    Recall

    Recall Number
    Z-0132-2023
    Event Number
    90924
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    LJT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 20, 2022
    Posted
    October 25, 2022
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    Description

    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

    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.

    Action

    Angiodynamics issued Urgent Medical Device Correction Letter on 09-20-2022 via Federal Express. Letter states reason for recall, health risk and action to take: Identify if any of the affected product is in your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Place the supplied Instructions for Use with each of the affected product(s) in your possession " Forward a copy of this recall notification and Instructions for Use to all sites to which you have distributed affected product. If you have any questions regarding the corrective action as stated above, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time). " If additional Instructions for Use are required, please note the quantity needed on the enclosed Reply Verification Tracking Form. " Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product affected by this correction). Email Reply Verification Tracking Form (preferred): [email protected] Fax Reply Verification Tracking Form: Attn: Vortex MP Correction Coordinator Fax number 1-855-273-0519

    Distribution

    US Nationwide distribution in the states of AZ, CA, DC, IN, PA.

    Quantity

    11 units