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U.S. Department of Health and Human Services

Class 2 Device Recall Codman (and Formerly MICRUS) NEUROPATH

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 Class 2 Recall
Codman (and Formerly MICRUS) NEUROPATH
see related information
Date Posted February 20, 2013
Recall Status1 Open
Recall Number Z-0843-2013
Recall Event ID 64158
Premarket Notification
510(K) Number
K052004 
Product Classification Catheter, Percutaneous - Product Code DQY
Product NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 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
Manufacturer Reason
for Recall
Sterility of device may be compromised due to lack of package integrity
FDA Determined
Cause 2
DESIGN: Packaging 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 in Commerce 19 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = VASCON LLC
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