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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 Device Recall Terumo Advanced Perfusion System 1see related information
Date Initiated by FirmJune 17, 2014
Date PostedJuly 08, 2014
Recall Status1 Terminated 3 on September 22, 2014
Recall NumberZ-2018-2014
Recall Event ID 68244
510(K)NumberK022947 
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
ProductTerumo 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 MI 48103-9586
For Additional Information Contact
734-741-6173
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		Labeling Change Control
ActionOn 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 Commerce1713 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DTQ
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