Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0132-2023 — 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: H

U.S. FDA — Device Enforcement · United States · 2022-09-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0132-2023
Date of alert: 2022-09-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Angiodynamics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15051684018357

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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