Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816. Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
FDA Recall Z-3073-2011 · Posted 2011-08-24
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Recalling FirmAngiodynamics, INC
Recall StatusTerminated
Product CodeGEI
Date Initiated2010-08-30
Date Terminated2012-03-12
Product Quantity527 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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