Z-2180-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2012
- Initiation Date
- June 15, 2012
- Termination Date
- February 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 boxes/35 units
Product Description
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.
Reason for Recall
AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.
Code Information
Lot: 564325