Terumo Cardiovascular Systems Corporation

0505258, 0510335, 0519809, 0524042, 0531107, 0533191, 0536444, 0538524, 0541634, 0545325, 0547867, 0552336, 0561753, 0561751, 0561752, 0557559, 0564337, 0570411, 0571613, 0573009, 0577882, 0581075, 0584965, 0587430, 0585731, 0585730, 0585732, 0598360, 0601970 and 0605113.

General and Plastic Surgery Devices

1

No

US, Indonesia, UAE, Hong Kong, Japan, Singapore, Malaysia, Taiwan, Belgium, Uraguay, Venezuela, Columbia, Mexico, Guam, Vietnam and Thailand.

Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI. || The sternal saw blades are indicated for use in medial sternotomoties. The saw blades are used wit the Sarns Sternal Saw System.

all lots of cables distributed prior to 1/4/2008.

Cardiovascular Devices

2

No

Worldwide Distribution: USA states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Belgium, Canada, Columbia, Chile, Costa Rica, Germany, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Korea, Mexico, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, Thailand, Taiwan, UAE and Vietnam.

Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI

Serial numbers 0001-1315.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, including the states of AL,AZ, CA, CO, CT, DC, FL, GA, HI, IA, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, and WV, and the countries of Canada, Indonesia, China, Chile, UAE, Japan, Singapore, UK, Malaysia, Taiwan, Belgium, Korea, Phiippines and Thailand.

Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed in the US)

Serial numbers 0001-1340.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, including the states of AL,AZ, CA, CO, CT, DC, FL, GA, HI, IA, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, and WV, and the countries of Canada, Indonesia, China, Chile, UAE, Japan, Singapore, UK, Malaysia, Taiwan, Belgium, Korea, Phiippines and Thailand.

Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo Cardiovascular System, Ann Arbor MI.

Lot 0500760.

Cardiovascular Devices

2

No

Worldwide Distribution --- including USA and countries of Australia, Belgium and Canada.

Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578. || The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.