Recall Z-3072-2011
Angiodynamics, INC · initiated August 30, 2010
Product
Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter, AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816 Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Codes / lots: Catalog number: MP-P5SDT, Batch number: 513796 and 517058
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-3072-2011
- Initiated
- August 30, 2010
- Posted by FDA
- August 24, 2011
- Terminated
- March 12, 2012
- Product code
- LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular
- Quantity
- 41 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-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 |
| Z-3074-2011 | Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices).…The labeling contains errors which result in the products being misbranded | 08/30/2010Terminated |