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Terminated

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

FDA Recall Z-0403-2011 · Posted 2010-11-17

Recalling FirmAngiodynamics, INC
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-09-27
Date Terminated2011-06-21
Product Quantitysee line one.

Reason for Recall

Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution : Throughout the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032557TRIUMPH VTX WITH LIFEVALVE CATHETERHorizon Medical Products, Inc. · 2003-09-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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