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U.S. Department of Health and Human Services

Class 2 Device Recall OptiPack Smart Perfusion Pack

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  Class 2 Device Recall OptiPack Smart Perfusion Pack see related information
Date Initiated by Firm December 30, 2009
Date Posting Updated March 12, 2010
Recall Status1 Terminated 3 on March 15, 2010
Recall Number Z-1084-2010
Recall Event ID 54250
510(K)Number K881330  
Product Classification Perfusion tubing set - Product Code DWF
Product Opti-Pack Smart Perfusion Pack, REF: 086500100, 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 Numbers: 0924300054, 0924400026, and 0933400046.
Recalling Firm/
Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004
For Additional Information Contact
Manufacturer Reason
for Recall
Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
FDA Determined
Cause 2
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 21 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 and Original Applicant = COBE LABORATORIES, INC.