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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns System 8000

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 Class 2 Recall
Sarns System 8000
see related information
Date Posted September 11, 2012
Recall Status1 Terminated on January 29, 2013
Recall Number Z-2348-2012
Recall Event ID 62321
Premarket Notification
510(K) Number
K915183 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.
Code Information catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action TERUMO Cardiovascular Systems communicated with their affiliate, Terumo Dubai, in 2009 at the time the complaints were reported. No further communication was warranted. For questions regarding this recall call 734-741-6173.
Quantity in Commerce 8
Distribution Worldwide distribution: International only-country of: Terumo Dubai, UAE
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 = 3M HEALTH CARE, SARNS
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