Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
This recall has been terminated (originally issued November 17, 2010).
- Company
- Angiodynamics, Inc
- Recall Initiated
- September 27, 2010
- Posted
- November 17, 2010
- Terminated
- June 21, 2011
- Recall Number
- Z-0402-2011
- Quantity
- 6000 units (includes all port systems listed)
- Firm Location
- Manchester, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
Distribution
Nationwide Distribution : Throughout the US.
Lot / Code Info
Catalogue Number: P530K, P5355K, P5405K, P4455K, P12105K, P12155K, P12305K and P12355.
Root 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.
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