| Class 2 Device Recall Habib, 4x Kit 4401 | |
Date Initiated by Firm | August 30, 2010 |
Date Posted | August 24, 2011 |
Recall Status1 |
Terminated 3 on March 12, 2012 |
Recall Number | Z-3073-2011 |
Recall Event ID |
59680 |
510(K)Number | K051420 |
Product Classification |
Electrosurgica Coagulation Accessory - Product Code GEI
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Product | 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. |
Code Information |
Catalog number: 4401, Batch number: 511828, 511831, 511833, 513066, 513788, 513999, 514624, 515274, and 516914. |
Recalling Firm/ Manufacturer |
Angiodynamics, INC 1 Horizon Way Manchester GA 31816-1749
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For Additional Information Contact | S. Michael Sharp, PhD 518-795-1123 |
Manufacturer Reason for Recall | The labeling contains errors which result in the products being misbranded |
FDA Determined Cause 2 | Labeling False and Misleading |
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. |
Quantity in Commerce | 527 units |
Distribution | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GEI
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