| Class 2 Device Recall Codman (and Formerly MICRUS) NEUROPATH | |
Date Initiated by Firm | January 11, 2013 |
Date Posted | February 20, 2013 |
Recall Status1 |
Terminated 3 on August 10, 2015 |
Recall Number | Z-0846-2013 |
Recall Event ID |
64158 |
510(K)Number | K052004 |
Product Classification |
Catheter, percutaneous - Product Code DQY
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Product | NEUROPATH 5Fx100 GUIDING CATH HH
Product Code: GMC51000000
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 MA 02767
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For Additional Information Contact | 508-880-8100 |
Manufacturer Reason for Recall | Sterility of device may be compromised due to lack of package integrity |
FDA Determined Cause 2 | 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 in Commerce | 234 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQY
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