Z-3074-2011

Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One...

Name: Z-3074-2011 Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One...
Creator: Angiodynamics, INC
Published: 2010-08-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-08-30 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics, INC began a recall of Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816. Intended to be used... on 2010-08-30. The reason FDA records is "The labeling contains errors which result in the products being misbranded". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3074-2011
Status: Terminated
Initiated: 2010-08-30
Posted: 2011-08-24
Terminated: 2012-03-12
Recalling firm: Boston Scientific Corporation
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The labeling contains errors which result in the products being misbranded
Root cause tag: labeling and UDI
FDA root cause: 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: 132 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
Product codes and lots: Catalog number: 4401L, Batch number: 511829, 511830, 513063 513519 and 513789.

Product code GEI

K051420Class IIHabib 4XEmcision , Ltd. / cleared 2005-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)