Terumo Cardiovascular Systems Corp

Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22.  Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0.  Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.

Cardiovascular Devices

2

No

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

Terumo Custom Cardiovascular and Perfusion Procedure Kits || Catalog Codes: Kits with a 5-digit code beginning with the digit 6: || Catalog Number: 6XXXX ; || Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX || Product usage: || The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.

Lot Numbers: MN08, MNI5, MM11, MM18, MM25.  Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.

Cardiovascular Devices

2

No

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

Terumo 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.

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

Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010  Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0

Cardiovascular Devices

2

No

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

Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass || Item Numbers: 5852, 16010 || Product Usage: || This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity

Lot: ME19

Cardiovascular Devices

2

No

Distribution USA and Canada

Terumo Cardiovascular Procedure Kit Custom || CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE || P/N: 71032