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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 Device Recall Sarns System 8000 see related information
Date Initiated by Firm August 12, 2009
Date Posted September 11, 2012
Recall Status1 Terminated 3 on January 29, 2013
Recall Number Z-2348-2012
Recall Event ID 62321
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/
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
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
Mixed-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 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 = DTQ and Original Applicant = 3M HEALTH CARE, SARNS