Class 2 Device Recall Smart Perfusion Pack

• Date Initiated by Firm: December 30, 2009
• Date Posted: March 12, 2010
• Recall Status: Terminated on March 15, 2010
• Recall Number: Z-1096-2010
• Recall Event ID: 54250
• 510(K)Number: K881330
• Product Classification: Perfusion tubing set - Product Code DWF
• Product: Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
• Code Information: Lot Number: 0932800048.
• 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: Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
• FDA Determined Cause: Packaging process control
• Action: Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.
• Quantity in Commerce: 17 units
• Distribution: AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
• 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 = DWF