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.
This recall has been terminated (originally issued August 24, 2011).
- Company
- Angiodynamics, Inc
- Recall Initiated
- August 30, 2010
- Posted
- August 24, 2011
- Terminated
- March 12, 2012
- Recall Number
- Z-3074-2011
- Quantity
- 132 units
- Firm Location
- Manchester, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The labeling contains errors which result in the products being misbranded
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
Lot / Code Info
Catalog number: 4401L, Batch number: 511829, 511830, 513063 513519 and 513789.
Root Cause
Labeling False and Misleading
Action Taken
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.