Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 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: MN08 Manufacturing Date November 8, 20 I 0.

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