Recall Z-0402-2011
Angiodynamics, INC · initiated September 27, 2010
Product
Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
Codes / lots: Catalogue Number: P530K, P5355K, P5405K, P4455K, P12105K, P12155K, P12305K and P12355.
Reason for recall
Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0402-2011
- Initiated
- September 27, 2010
- Posted by FDA
- November 17, 2010
- Terminated
- June 21, 2011
- Product code
- FRN – Pump, Infusion
- Quantity
- 6000 units (includes all port systems listed)
- Distribution
- Nationwide Distribution : Throughout the US.
- Recalling firm
- Angiodynamics, INC, Manchester, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0403-2011 | Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |
| Z-0404-2011 | Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |
| Z-0405-2011 | LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |
| Z-0406-2011 | Triumph-1, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit… | 09/27/2010Terminated |