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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Codman (and Formerly MICRUS) NEUROPATH		see related information
Date Posted February 20, 2013
Recall Number Z-0848-2013
Product NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code Information All unexpired lots
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767
Consumer Instructions No consumer action necessary
Reason for
Recall		 Sterility of device may be compromised due to lack of package integrity
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 in Commerce 273 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 Switzerland.
 
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