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U.S. Department of Health and Human Services

Class 2 Device Recall Electrical Venous Occluder

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 Class 2 Recall
Electrical Venous Occluder
see related information
Date Posted July 22, 2010
Recall Status1 Terminated on July 21, 2010
Recall Number Z-2075-2010
Recall Event ID 56139
Premarket Notification
510(K) Number
K082344 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
Code Information Serial number: 12K01077.
Recalling Firm/
Manufacturer
Sorin Group USA, Inc.
14401 W 65th Way
Arvada, Colorado 80004
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943.
Quantity in Commerce 1 unit
Distribution CA, PA, TN.
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 = DWF and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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