Recall Z-3074-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Angiodynamics, INC
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.
| Date | Aug 24, 2011 (initiated Aug 30, 2010) |
| Status | Terminated |
| Reason | The labeling contains errors which result in the products being misbranded |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051420 | HABIB 4X Emcision , Ltd., Aug 15, 2005 |