Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central v
Summary
The FDA issued a Class II for Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Cat by Angiodynamics, Inc.. Reason: Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedu.
Details
Source
Device Recall
External ID
Z-0132-2023
Action Date
2022-11-02
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025
Quantity Affected: 11 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-20
Company
Queensbury, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 128 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Angiodynamics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Angiodynamics, Inc. have FDA actions?
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0132-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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