Device 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.
Z-2180-2012
Product summary
- Event
- Event 62341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 boxes/35 units
- Official record key
device-enforcement:Z-2180-2012
Official wording
Reason: AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.
Code information: Lot: 564325
Distribution pattern: Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.
Derived failure modes
-
Labeling or packaging
mislabeled