FDAFDA · Food and drugs·Recall number Z-0864-2013
NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Published February 27, 2013 · Recall initiated: January 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of device may be compromised due to lack of package integrity
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Codman & Shurtleff, Inc.
- Distributor
- 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.
- Lot
- All unexpired lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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