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U.S. Department of Health and Human Services

Class 2 Device Recall Apex HP PHisio

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  Class 2 Device Recall Apex HP PHisio see related information
Date Initiated by Firm December 02, 2011
Date Posted January 14, 2012
Recall Status1 Terminated 3 on June 13, 2012
Recall Number Z-0764-2012
Recall Event ID 60737
510(K)Number K083021  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Apex HP PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy.

Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
Code Information All Lots.
Recalling Firm/
Manufacturer		 Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004
For Additional Information Contact Jack Ellison
303-467-6306
Manufacturer Reason
for Recall		 Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
FDA Determined
Cause 2		 Device Design
Action Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
Quantity in Commerce 22,100 units (each sold as part of a pack)
Distribution Worldwide Distribution
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 = DTZ and Original Applicant = SORIN GROUP ITALIA S.R.L.
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