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U.S. Department of Health and Human Services

Class 2 Device Recall Perfusion Tubing Set

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  Class 2 Device Recall Perfusion Tubing Set see related information
Date Initiated by Firm October 07, 2010
Date Posted November 15, 2010
Recall Status1 Terminated 3 on December 17, 2010
Recall Number Z-0386-2011
Recall Event ID 57052
510(K)Number K881330  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503000, Manufactured by 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 No. 1022400018, 1022800031
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		 Defective product packaging may compromise product sterility.
FDA Determined
Cause 2		 Packaging process control
Action Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible. For further information, contact 1-800-650-2623.
Quantity in Commerce 13
Distribution Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
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.
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