Terumo Medical Corporation

Please see Attachment 3

Cardiovascular Devices

2

No

Nationwide Distribution

PINNACLE¿ Introducer Sheath || PINNACLE PRECISION ACCESS SYSTEM¿ Sheath || PINNACLE¿ TIF TIP" Introducer Sheath || PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath

Terumo Product Code - RSR01  Affected Lot Numbers  RN19  RN26  RP03

Cardiovascular Devices

2

No

Nationwide Distribution.

Destination Renal Guiding Sheath || Intended for the introduction of interventional and diagnostic devices into the human vasculature.

PRODUCT CODE  3SR-OX2225CA 3SR-OX2419CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2419CA 3SR-OX2225CA SR-TL2225M 3SR-OX2225CA 3SR-OX2419CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA SR-TL2225M 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2419CA 3SR-OX2419CA 3SR-OX2419CA  LOT NUMBER  RF2727 RF2727 RG0227 RG0927 RG0927 RG1627 RG2027 RG2027 RG2327 RH0727 RH1427 RH1427 RH1427 RH2127 RH2827 RH3127 RK0427 RK0427 RK1127 RK1827 RK2527 RL0227 RL0227 RL0827 RL1527 RL2227

General Hospital and Personal Use Devices

2

No

US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.

SurFlo IV Catheter

RSC02

Cardiovascular Devices

2

No

Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama

Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

RSR08

Cardiovascular Devices

2

No

Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama

Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.