Device Recall Integrated Cardioplegia Delivery Sets

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

Cardiovascular Devices

1

No

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

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