Recall Z-0402-2011 ยท FRN Pump, Infusion
Angiodynamics, INC
Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
| Date | Nov 17, 2010 (initiated Sep 27, 2010) |
| Status | Terminated |
| Reason | Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set. |
| Root cause | Other |
| Action | 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. |
| Quantity | 6000 units (includes all port systems listed) |
| Distribution | Nationwide Distribution : Throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010189 | VORTEX ACCESS SYSTEM Horizon Medical Products, Inc., Feb 12, 2001 |