—#106341

Product

Apex 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.

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K020997
Affected lot / code info: All Lots.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2011-12-02
Posted by FDA: 2012-01-14
Terminated: 2012-06-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.