Recall Z-0862-2013 ยท DQY Catheter, Percutaneous
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
| Date | Feb 20, 2013 (initiated Jan 11, 2013) |
| Status | Terminated |
| Reason | Sterility of device may be compromised due to lack of package integrity |
| Root cause | Component design/selection |
| Action | Codman sent an Urgent Voluntary Product Recall Notification letter dated January 11, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check all inventory to determine if they have any affected product, use the included instructions to report inventory status, return and obtain replacement product. Customers were instructed to contact your local Codman Representative or Stericycle at 1-866-201-9077. For questions regarding this recall call 508-880-8100. |
| Quantity | 10 units |
| Distribution | 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 Switzerl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052004 | VASCON NEUROPATH GUIDING CATHETER Vascon, LLC, Jan 19, 2006 |