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U.S. Department of Health and Human Services

Class 2 Device Recall BCare 5

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  Class 2 Device Recall BCare 5 see related information
Date Initiated by Firm June 18, 2010
Date Posted July 22, 2010
Recall Status1 Terminated 3 on July 21, 2010
Recall Number Z-2074-2010
Recall Event ID 56139
510(K)Number K092463  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.
Code Information Serial numbers: 25K20055, 25K20060.
Recalling Firm/
Manufacturer		 Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004
For Additional Information Contact
303-467-6306
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		 PMA
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 2 units
Distribution CA, PA, TN.
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.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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