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U.S. Department of Health and Human Services

Class 2 Device Recall 50 Portal Vein Cannula

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  Class 2 Device Recall 50 Portal Vein Cannula see related information
Date Initiated by Firm May 10, 2012
Date Posted May 17, 2012
Recall Status1 Terminated 3 on August 15, 2013
Recall Number Z-1625-2012
Recall Event ID 61859
Product Classification Catheter (gastric, colonic, etc.), irrigation and aspiration - Product Code KDH
Product 50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205

For use in humans. No indication of use is on the label. However, the device can be used for infusion.
Code Information Lot 120493
Recalling Firm/
Manufacturer		 MEDDEV USA, INC.
100 Highland Park Vlg FL 200
Dallas TX 75205-2720
For Additional Information Contact
214-692-3559
Manufacturer Reason
for Recall		 The device was marketed without a 510(k) and is not sterile.
FDA Determined
Cause 2		 No Marketing Application
Action MEDDEV USA, Inc decided to recall and notified their customer by phone on 05/10/12. Customers were instructed to return the entire shipment to MEDDEV . For questions regarding this recall call 214-692-3559.
Quantity in Commerce 20 units
Distribution Nationwide Distribution including Illinois
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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