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U.S. Department of Health and Human Services

Class 3 Device Recall Alcon Trocar Cannula Replacement Plug

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  Class 3 Device Recall Alcon Trocar Cannula Replacement Plug see related information
Date Initiated by Firm January 18, 2007
Date Posted March 13, 2007
Recall Status1 Terminated 3 on September 24, 2010
Recall Number Z-0610-2007
Recall Event ID 37147
Product Classification Trocar Cannula Replacement Plug - Product Code NGY
Product 19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.
Code Information Lot F58507
Recalling Firm/
Manufacturer		 Alcon Research, Ltd
6201 South Fwy
Fort Worth TX 76134-2001
Manufacturer Reason
for Recall		 Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula Plugs.
FDA Determined
Cause 2		 Other
Action Recalled by letter on January 22, 2007.
Quantity in Commerce 15 units.
Distribution Nationwide- Hospitals in MD and MN.
Total Product Life Cycle TPLC Device Report
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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