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U.S. Department of Health and Human Services

Class 2 Device Recall Hollow Fiber Oxygenator

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  Class 2 Device Recall Hollow Fiber Oxygenator see related information
Date Initiated by Firm August 08, 2008
Date Posted September 30, 2008
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = DIDECO S.P.A.
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