FDA Medical Device Recalls (openFDA)
Angiodynamics, INC: Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
- Recall number
- Z-0404-2011
- Recalling firm
- Angiodynamics, INC
- Product
- Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
- Status
- Terminated
- Initiated
- 2010-09-27
- Posted
- 2010-11-17
- Terminated
- 2011-06-21
- 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
- see product one.
- Distribution
- Nationwide Distribution : Throughout the US.
- Lot, serial or model codes
- Catalogue Number: LVTX5557, SVTX7515, LVTX5015, LVTX5213, LVTX71513, LVTX7015, LVTX7013, LVTX5513, LVTX5057, LVTX5013 and LVTX5555.
- 510(k) numbers
- ["K010767"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3017892510
- Firm city
- Manchester
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28