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U.S. Department of Health and Human Services

Class 2 Device Recall Integrated Cardioplegia Delivery Sets

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  Class 2 Device Recall Integrated Cardioplegia Delivery Sets 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-0157-2015
Recall Event ID 58185
510(K)Number K810079  
Product Classification Accessory equipment, cardiopulmonary bypass - Product Code KRI
Product Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852
Item Number: 16110

Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity
Code Information Lot Numbers: ML13, MM04.  Manufacturing datese September 13, 2010 through October 4, 20 I 0.
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 165 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.
510(K) Database 510(K)s with Product Code = KRI and Original Applicant = 3M HEALTH CARE, SARNS
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