Device Recall Conducer Cardioplegia Set SITH MP4

Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0.  Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3  Manufacturing dates March 15, 2010 through December 13, 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- || Catalog Number:165720 and Catalog Number: 6375 || Product Usage: || 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: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.