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Vortex recallZ-0132-2023 · Angiodynamics, Inc. · initiated Sep 20, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-0132-2023
Status
Open, Classified
Initiated by the company
Sep 20, 2022
Posted by the FDA
Oct 25, 2022
Recalling firm
Angiodynamics, Inc.
Quantity
11 units
Product code
LJT
FDA submissions
K033473
Distribution
US Nationwide distribution in the states of AZ, CA, DC, IN, PA.

Product 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

Code information (models, lots, serial numbers)

UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

2 devices cleared under K033473 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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