| Class 2 Device Recall Apex | |
Date Initiated by Firm | December 02, 2011 |
Date Posted | January 14, 2012 |
Recall Status1 |
Terminated 3 on June 13, 2012 |
Recall Number | Z-0760-2012 |
Recall Event ID |
60737 |
510(K)Number | K014080 |
Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
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Product | Apex Oxygenator, 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
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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 | 19,808 (9,550 stand alone/ 10,258 in packs) |
Distribution | Worldwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DTZ
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