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U.S. Department of Health and Human Services

Class 2 Device Recall TERUMO 3T L. V. Control Valve

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  Class 2 Device Recall TERUMO 3T L. V. Control Valve see related information
Date Initiated by Firm August 11, 2011
Date Posted September 16, 2011
Recall Status1 Terminated 3 on March 20, 2012
Recall Number Z-3228-2011
Recall Event ID 59704
510(K)Number K001245  
Product Classification Cardiovascular, Cpb Check Valve, Retrograde Flow, In-line - Product Code MJJ
Product Cardiovascular Custom Procedure Kits, REV.2, REV. 3
PUMP & TABLE PACK 1/4
Terumo Cardiovascular Systems, Ashland, MA 0172
Item Number: 71038-05
Terumo Cardiovascular Systems Corp.

The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

Code Information Lot Numbers:  ME19  MG21  MK02  MM04  MN29  MP06  NF16  NH11     
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information Contact Same
508-231-2400
Manufacturer Reason
for Recall
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
FDA Determined
Cause 2
Nonconforming Material/Component
Action Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers. The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm. For questions on this recall contact Terumo Customer Service at (734) 525-9580.
Quantity in Commerce 50 units
Distribution Nationwide Distribution, including the states of FL and MI.
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 = MJJ and Original Applicant = 3T MEDICAL SYSTEMS, LLC.
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