Date Initiated by Firm |
June 04, 2013 |
Date Posted |
December 27, 2013 |
Recall Status1 |
Terminated 3 on October 01, 2014 |
Recall Number |
Z-0603-2014 |
Recall Event ID |
67064 |
510(K)Number |
K820297
|
Product Classification |
Valve, pressure relief, cardiopulmonary by Medical - 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 MD 21921-5315
|
For Additional Information Contact |
410-392-7102
|
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 design/selection |
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 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 = MNJ and Original Applicant = C.R. BARD, INC.
|