Vortex VX Port, AngioDynamics, Inc., One Horizon Way… recallZ-0402-2011 · Angiodynamics, INC · initiated Sep 27, 2010
Terminated All recalls posted in November 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics, INC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
FDA root cause category: Other
What the company is doing
AngioDynamics issued a Notification of Medical Device Correction letter dated September 27, 2010 to customers. The notification served to make the customer aware of the mislabeling. Customers were instructed not to return the affected products. Customers can contact AngioDynamics at 1 800 772-6446 about this correction.
Recall details
- Recall number
- Z-0402-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 27, 2010
- Posted by the FDA
- Nov 17, 2010
- Recalling firm
- Angiodynamics, INC
- Quantity
- 6000 units (includes all port systems listed)
- Product code
- FRN
- FDA submissions
- K010189
- Distribution
- Nationwide Distribution : Throughout the US.
Product description
Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
Code information (models, lots, serial numbers)
Catalogue Number: P530K, P5355K, P5405K, P4455K, P12105K, P12155K, P12305K and P12355.
Other devices under the same FDA submission
6 devices cleared under K010189 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vortex P5405KNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- Vortex P5305KNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- Vortex P5455KNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- Vortex P12155KAngiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Vortex P5355KNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Vortex P12105KAngiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 56876).
- Z-0403-2011 · TerminatedVortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
- Z-0404-2011 · TerminatedVortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
- Z-0405-2011 · TerminatedLifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.
- Z-0406-2011 · TerminatedTriumph-1, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page