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U.S. Department of Health and Human Services

Class 2 Device Recall Sorin Group

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 Class 2 Recall
Sorin Group
see related information
Date Posted January 14, 2012
Recall Status1 Terminated on June 13, 2012
Recall Number Z-0771-2012
Recall Event ID 60737
Product Classification Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
Product PTS Heart/Lung Perfusion Pack Labeling Sterile EO, Product is manufactured by Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004 (utilizing oxygenators 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, Colorado 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
DESIGN: Labeling 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 194,807 packs (10,258 Apex; 10,543 Apex Smarxt; 12,341 Apex Phisio; 4,763 Apex HP; 22,100 Apex HP Phisio; 104,783 Primo2x; 30,019 Synthesis Phisio)
Distribution Worldwide Distribution
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.
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