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

Reason: 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

Code information: Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.

Distribution pattern: Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.