FDAFDA · Food and drugs·Recall number Z-2180-2012
AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.
Published August 15, 2012 · Recall initiated: June 15, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics Worldwide Headquarters
- Distributor
- Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.
- Lot
- Lot: 564325
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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