NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
This recall has been terminated (originally issued February 20, 2013).
- Company
- Codman & Shurtleff, Inc.
- Recall Initiated
- January 11, 2013
- Posted
- February 20, 2013
- Terminated
- August 10, 2015
- Recall Number
- Z-0864-2013
- Quantity
- 25
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility of device may be compromised due to lack of package integrity
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 Switzerland.
Lot / Code Info
All unexpired lots
Root Cause
Component design/selection
Action Taken
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.