Z-0404-2011

Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816

Name: Z-0404-2011 Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
Creator: Angiodynamics, INC
Published: 2010-09-27
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-09-27 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics, INC began a recall of Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 on 2010-09-27. The reason FDA records is "Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0404-2011
Status: Terminated
Initiated: 2010-09-27
Posted: 2010-11-17
Terminated: 2011-06-21
Recalling firm: Boston Scientific Corporation
Product: Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
Product code: FRN Pump, Infusion
Reason for recall: Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
Root cause tag: labeling and UDI
FDA 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 in commerce: see product one.
Distribution: Nationwide Distribution : Throughout the US.
Product codes and lots: Catalogue Number: LVTX5557, SVTX7515, LVTX5015, LVTX5213, LVTX71513, LVTX7015, LVTX7013, LVTX5513, LVTX5057, LVTX5013 and LVTX5555.

Product code FRN

K010767Class IILifeport Vtx Access System,model Vtx 7000 SeriesHorizon Medical Products, Inc. / cleared 2001-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)