Class 2 Device Recall Hollow Fiber Oxygenator

• Date Initiated by Firm: August 08, 2008
• Date Posted: September 30, 2008
• Recall Status: Terminated on September 30, 2008
• Recall Number: Z-2469-2008
• Recall Event ID: 49378
• 510(K)Number: K991737
• Product Classification: Oxygenator - Product Code DTZ
• Product: Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmonary bypass circuits as a device to replace the function of the lungs in order to control the arterial/venous temperature and as a venous blood reservoir
• Code Information: Lot No: 0501210038, and 0710290112.
• Recalling Firm/ Manufacturer: Sorin Group USA, Inc.; 14401 W 65th Way; Arvada CO 80004
• For Additional Information Contact: 303-467-6306
• Manufacturer Reason for Recall: Under certain conditions, venous reservoir on oxygenator may allow air into the system.
• FDA Determined Cause: Labeling False and Misleading
• Action: The firm sent out a notification letter, by certified letter, on Aug 8,2008. Instructions on how to prevent air from entering the system were provided. Sorin Group USA, Inc. can reached at 1-303-467-6306.
• Quantity in Commerce: 35 units
• Distribution: NC
• 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