| Class 2 Device Recall Vortex MPP5SAT Port | |
Date Initiated by Firm | August 30, 2010 |
Date Posted | August 24, 2011 |
Recall Status1 |
Terminated 3 on March 12, 2012 |
Recall Number | Z-3071-2011 |
Recall Event ID |
59680 |
510(K)Number | K033473 |
Product Classification |
Intravascular Catheter, Subcutaneous - Product Code LJT
|
Product | 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. |
Code Information |
Catalog number: MP-P5SAT, Batch numbers: 513795 and 514961. |
Recalling Firm/ Manufacturer |
Angiodynamics, INC 1 Horizon Way Manchester GA 31816-1749
|
For Additional Information Contact | S. Michael Sharp, PhD 518-795-1123 |
Manufacturer Reason for Recall | The labeling contains errors which result in the products being misbranded |
FDA Determined Cause 2 | 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 in Commerce | 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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LJT
|
|
|
|