Enforcement Report - Week of February 27, 2013
-
Back to Previous Page
Product Detail
| Product Description | NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices |
|---|---|
| Recall Number | Z-0843-2013 |
| Classification | Class II |
| Code Info | All unexpired lots |
| Product Distributed Qty | 19 units |
| Reason For Recall | Sterility of device may be compromised due to lack of package integrity |
Event Detail
| Event Id | 64158 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Codman & Shurtleff, Inc. |
| City | Raynham |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland. |
-
