Procedure Kit

Lot numbers: MD15, and  MD26

Cardiovascular Devices

2

No

The products were distributed nationwide.

Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03

Lot Number MD29

Cardiovascular Devices

2

No

The products were distributed nationwide.

Cardiovascular Procedure Kit || Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485

Lot Number ME19

Cardiovascular Devices

2

No

The products were distributed nationwide.

Cardiovascular Procedure Kit || X-Coated H/L pack with Cardioplegia, Item # 70067-03

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.

BATCH 2010062150

General and Plastic Surgery Devices

2

No

Nationwide Distribution

Material DT12210, CENTRAL LINE PROCEDURE KIT, CENTURION CENTRAL LINE PROCEDURE KIT, REORDER DT12210, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com || FACILITATES LINE INSERTION || DT12050 PORT ACCESS TRAY