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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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 Class 2 Recall
Terumo Advanced Perfusion System 1
see related information
Date Posted July 08, 2014
Recall Status1 Open
Recall Number Z-2018-2014
Recall Event ID 68244
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo® Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Code Information Catalog Number 801763
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action On June 17, 2014, TCVS sent URGENT MEDICAL DEVICE RECALL notification to consignees. Notification included reason for recall, potential hazard, correction, affected population, and customer instructions. Questions concerning the recall are directed to Terumo CVS Customer Service @ 800-521-2818 (M-F, 8am-6pm).
Quantity in Commerce 1713 units
Distribution Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.
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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