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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced Perfusion System 1

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 Class 2 Recall
Advanced Perfusion System 1
see related information
Date Posted November 29, 2011
Recall Status1 Terminated on August 22, 2012
Recall Number Z-0299-2012
Recall Event ID 59581
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Code Information Lot numbers: 0006-1415; Catalog # 801764 System 1 Base, 220 V
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
For Additional Information Contact Tracy Bellanca
734-741-6056
Manufacturer Reason
for Recall
1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12) cables from Terumo Japan, which were in product development, were given to a US customer.
FDA Determined
Cause 2
DESIGN: Device Design
Action Terumo sent an URGENT MEDICAL DEVICE CORRECTION: Recall Notification dated November 8, 2011 to all affected customers. The letter described the reason for the recall, known/potential hazards and request immediate location and correction of product. The letter instructs customers to stop using the modified cables and return to Terumo for replacement and destruction. Customers were asked to complete the attached response form and fax to the number indicated on the form. All affected customers will be receiving a safety advisory to advise them that Terumo do not recommend the alternative configuration of a System 1 Base with an 8K Occluder. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818 or 1-800-292-6551 (fax).
Quantity in Commerce 12 units
Distribution Worldwide Distribution - (USA) Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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