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.
FDA Recall Z-0771-2012 · Posted 2012-01-14
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Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDTZ
Date Initiated2011-12-02
Date Terminated2012-06-13
Product Quantity194,807 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)
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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