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Terminated

Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter, AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816 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.

FDA Recall Z-3072-2011 · Posted 2011-08-24

Recalling FirmAngiodynamics, INC
Recall StatusTerminated
Product CodeLJT
Date Initiated2010-08-30
Date Terminated2012-03-12
Product Quantity41 units

Reason for Recall

The labeling contains errors which result in the products being misbranded

Firm Action

AngioDynamics, Inc. sent out a "Medical Device Recall" letter dated August 30, 2010 to all affected customers. The letter included; products affected, problem and asked them to return the product back to AngioDynamics. Customers were asked to fill out and return the included Recall Reply Form. For question on this recall contact AngioDynamics at (800) 772-6446.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide Distribution: (USA) Nationwide distribution and the countries of Austria, China, Denmark, Egypt, France Germany, India, Italy, Latvia, Netherlands, Poland, Russian Federation, South Africa, Switzerland and the United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032754VORTEX MPHorizon Medical Products, Inc. · 2003-09-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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