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U.S. Department of Health and Human Services

Class 2 Device Recall Habib, 4x Kit 4401

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  Class 2 Device Recall Habib, 4x Kit 4401 see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = EMCISION, LTD.
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