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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Custom Cardiovascular and Perfusion Procedure Kits

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  Class 2 Device Recall Terumo Custom Cardiovascular and Perfusion Procedure Kits see related information
Date Initiated by Firm March 01, 2011
Date Posted October 31, 2014
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-0159-2015
Recall Event ID 58185
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product Terumo Custom Cardiovascular and Perfusion Procedure Kits
Catalog Codes: Kits with a 5-digit code beginning with the digit 6:
Catalog Number: 6XXXX ;
Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX

Product usage:
The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. 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.
Code Information Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22.  Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0.  Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.
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		 Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.
FDA Determined
Cause 2		 Device Design
Action Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.
Quantity in Commerce Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units
Distribution Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
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.
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