# FDA recall Z-0132-2023

> **Angiodynamics, Inc.** · Class II · device recall initiated 2022-09-20.

## 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

## 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.

## Key facts

- **Recall number:** Z-0132-2023
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-20
- **Report date:** 2022-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0132-2023

## Citation

> AI Analytics. FDA recall Z-0132-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0132-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*