—#196221

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

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K033473
Affected lot / code info: UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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): recall@angiodynamics.com Fax Reply Verification Tracking Form: Attn: Vortex MP Correction Coordinator Fax number 1-855-273-0519

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

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

Timeline

Recall initiated: 2022-09-20
Posted by FDA: 2022-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196221. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.