—#103265

Product

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 product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K032754
Affected lot / code info: Catalog number: MP-P5SDT, Batch number: 513796 and 517058

Why it was recalled

The labeling contains errors which result in the products being misbranded

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Angiodynamics, INC
Address: 1 Horizon Way, Manchester, Georgia 31816-1749

Distribution

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

Timeline

Recall initiated: 2010-08-30
Posted by FDA: 2011-08-24
Terminated: 2012-03-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.