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U.S. Department of Health and Human Services

Class 2 Device Recall Clear Cardioplegia Delivery Sets

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 Class 2 Device Recall Clear Cardioplegia Delivery Setssee related information
Date Initiated by FirmMarch 01, 2011
Date PostedOctober 31, 2014
Recall Status1 Terminated 3 on November 06, 2014
Recall NumberZ-0158-2015
Recall Event ID 58185
510(K)NumberK823451 
Product Classification Heat-exchanger, cardiopulmonary bypass - Product Code DTR
ProductTerumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
Code Information Lot Numbers: MN08, MNI5, MM11, MM18, MM25.  Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information ContactSame
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
ActionTerumo 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 Commerce777 units
DistributionWorldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTR
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