Recall Z-3074-2011
Angiodynamics, INC · initiated August 30, 2010
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.
Codes / lots: Catalog number: 4401L, Batch number: 511829, 511830, 513063 513519 and 513789.
Reason for recall
The labeling contains errors which result in the products being misbranded
FDA-determined 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.
Details
- Recall number
- Z-3074-2011
- Initiated
- August 30, 2010
- Posted by FDA
- August 24, 2011
- Terminated
- March 12, 2012
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 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
- Recalling firm
- Angiodynamics, INC, Manchester, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3071-2011 | Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter…The labeling contains errors which result in the products being misbranded | 08/30/2010Terminated |
| Z-3072-2011 | Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter…The labeling contains errors which result in the products being misbranded | 08/30/2010Terminated |
| Z-3073-2011 | Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices).…The labeling contains errors which result in the products being misbranded | 08/30/2010Terminated |