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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Cardiovacular

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 Class 2 Recall
Terumo Cardiovacular
see related information
Date Posted December 27, 2013
Recall Status1 Open
Recall Number Z-0603-2014
Recall Event ID 67064
Premarket Notification
510(K) Number
K820297 
Product Classification Valve, Pressure Relief, Cardiopulmonary Bypass - Product Code MNJ
Product Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Code Information N/A
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton, Maryland 21921-5315
Manufacturer Reason
for Recall
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Terumo Cardiovascular issued Customer notification letters on June 4, 2013. Accounts advised to: Review this notice and decide to continue to use or not use the Cardiovascular Procedure Kits as configured until a replacement kit with a one-way valve indicated for use on the arterial side of the perfusion circuit is available. If you have questions, contact Terumo CVS Customer Service: 800-521-2818.
Quantity in Commerce 24,227.
Distribution Nationwide Canada
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 = MNJ and Original Applicant = C.R. BARD, INC.
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