PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 2, 2022 Initiated: September 20, 2022 #Z-0132-2023

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

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.

Details

Recalling Firm
Angiodynamics, Inc.
Units Affected
11 units
Distribution
US Nationwide distribution in the states of AZ, CA, DC, IN, PA.
Location
Queensbury, NY

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Angiodynamics, Inc.. Units affected: 11 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 2, 2022. Severity: Moderate. Recall number: Z-0132-2023.

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