| Class 2 Device Recall Codman |  |
Date Initiated by Firm | March 21, 2011 |
Date Posted | June 29, 2011 |
Recall Status1 |
Terminated 3 on February 17, 2016 |
Recall Number | Z-2701-2011 |
Recall Event ID |
58145 |
HDE Number | H060001 |
Product Classification |
Intracranial neurovascular stent - Product Code NJE
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Product | CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm
Product code: ENF452812 |
Code Information |
Lot Numbers: 01420432, 01420851, 01421192, 01421315, 01421338, 01421601, 01421949, 01422123, 01422396, 01422401, 02420432, VV1419796 |
Recalling Firm/ Manufacturer |
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham MA 02767
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For Additional Information Contact | SAME 508-880-8100 |
Manufacturer Reason for Recall | Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length. |
FDA Determined Cause 2 | Labeling design |
Action | Codman & Shurtleff, Inc.sent an "Urgent Medical Device Correction Notice" on March 21, 2011.
The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed.
It is NOT required to return any of this product to Codman.
Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative |
Quantity in Commerce | 380 units |
Distribution | Worldwide - Nationwide (USA), Canada, Korea. |
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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HDE Database | HDEs with Product Code = NJE
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