Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One Horizon Way, Ma
FDA device recall Z-3074-2011 · posted 2011-08-24 · Terminated
Recall details
- Recalling firm
- Angiodynamics, INC
- Reason for recall
- The labeling contains errors which result in the products being misbranded
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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,
- Date initiated
- 2010-08-30
- Date posted
- 2011-08-24
- Date terminated
- 2012-03-12
- Location
- Manchester, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HABIB 4X (K051420) | Emcision , Ltd. | 2005-08-15 |