Angiodynamics Worldwide Headquarters recalls AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guid

Recalled August 15, 2012 · FDA recall Z-2180-2012 · Angiodynamics Worldwide Headquarters

Hazard

AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled. · FDA Class II

Units

7 boxes/35 units

Sold at

Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.

Description

AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.

Product

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.

Manufacturer(s)

Angiodynamics Worldwide Headquarters

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →