Enforcement Report - Week of August 15, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-2180-2012 |
| Classification | Class II |
| Code Info | Lot: 564325 |
| Product Distributed Qty | 7 boxes/35 units |
| 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. |
Event Detail
| Event Id | 62341 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Angiodynamics Worldwide Headquarters |
| City | Latham |
| State | NY | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-15 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland. |
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