Recall Z-3071-2011 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Angiodynamics, INC
Vortex MP Port Single Titanium Port with Attached (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.
| 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 | 69 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
| K033473 | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT Horizon Medical Products, Inc., Nov 18, 2003 |