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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Modular Perfusion System 8000, Circuit Board for MBattery Module

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 Class 2 Recall
Sarns Modular Perfusion System 8000, Circuit Board for MBattery Module
see related information
Date Posted November 29, 2011
Recall Status1 Terminated on February 17, 2012
Recall Number Z-0303-2012
Recall Event ID 59479
Premarket Notification
510(K) Number
K915183 
Product Classification Pump, Blood, Cardiopulmonary Bypass, Roller Type - Product Code DWB
Product Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.
Code Information Catalog Number 16422 Serial Number 1901
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 is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Terumo conducted a Correction/Removal - Customer Communicated Script on November 7, 2011 to the affected customer. The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module. A replacement date was set for November 7, 2011. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.
Quantity in Commerce 10 units
Distribution Nationwide Distribution (USA) including the state of San Antonio, TX
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 = DWB and Original Applicant = 3M HEALTH CARE, SARNS
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