Recalls / —
—#94847
Product
Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K032557
- Affected lot / code info
- Catalogue Number: SPDX-14-1, SPAX-16-1, SSDX-10-1, SSAX-14-1, SSAX-16-1, SSDX-16-1, PSAX-10-1, PSDX-10-1, SPDX-16-1 and SSDX-14-1.
Why it was recalled
Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Angiodynamics, INC
- Address
- 1 Horizon Way, Manchester, Georgia 31816-1749
Distribution
- Distribution pattern
- Nationwide Distribution : Throughout the US.
Timeline
- Recall initiated
- 2010-09-27
- Posted by FDA
- 2010-11-17
- Terminated
- 2011-06-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #94847. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.