Lot Number: TE06

Nationwide Distribution including CA, CT , FL , WI.

Terumo Custom Cardiovascular Procedure Kit Tubing Pack || P/N: 66041-1 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.

Lot Numbers: TD02,TD02A, TD23, TD23A

Nationwide Distribution including CA, CT , FL , WI.

Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak || P/N: 73124 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Lot Numbers: TD02, TD16

Nationwide Distribution including CA, CT , FL , WI.

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE || P/N: 7928-03 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Lot Numbers: TD02

Nationwide Distribution including CA, CT , FL , WI.

Terumo Custom Cardiovascular Procedure Kit X-Coated || Pediatric Pack || P/N: 74039-02 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Lot Numbers: TD23

Nationwide Distribution including CA, CT , FL , WI.

Terumo Custom Cardiovascular Procedure Kit X-Coated || Perfusion Pack || P/N: 74077-01 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Lot Number: TD02

Nationwide Distribution including CA, CT , FL , WI.

Terumo Custom Cardiovascular Procedure Kit X-Coated || PED/Adult Main Pack || P/N: 75185 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Lot Number: TC23

Nationwide Distribution including CA, CT , FL , WI.

Terumo Custom Cardiovascular Procedure Kit X-Coated || PED/Adult Main Pack || P/N: 75529 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Serial Number Range 70194 through 70504

Cardiovascular Devices

1

No

Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .

Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel

Catalog Number: 401-231, Product Description: Titan" Stabilizer Attachment , Lot Number: 052R   Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R, 040 , 048R

Cardiovascular Devices

1

No

The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer || Attachment

Product code: 195240 Batch Numbers 616814, 618558, 619369, and 619396.  Lot codes: 123360, 129471, 29371-1, 29371-2, 36281, 40406, 42244, 44233, 49385, 51662, 56778, 58289, 61740, 64408, 68194, 70674, 75069, 78925, 80039, 82191, 86889, 90106, 90332, 91899, 98907, 99493, 99495, 101524, 105072, and 105808.

Cardiovascular Devices

1

No

Worldwide Distribution -- Nationwide Distribution, and the island of Puerto Rico.

Terumo Sarns Level Sensor II Pads. || Terumo Cardiovascular Systems Corporation. || Used to attach level sensors to the sides of the venous reservoir.

Catalog number 6090, Serial Numbers 0 - 10186

General and Plastic Surgery Devices

1

No

Worldwide Distribution - USA, and the countries of Colombia, Argentina, Lebanon, Belgium, Chile, India, Sri Lanka, Jordan, Egypt, Mexico, Brazil, Taiwan, Honduras, Canada, Germany, Singapore, Republic of Georgia, Hong Kong, Japan, UAE, Philippines, Thailand and South Africa.

Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery.

Serial numbers 5866 through 5887.

General and Plastic Surgery Devices

1

No

Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.

Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. || Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

Serial numbers 1877 through 1925.

General and Plastic Surgery Devices

1

No

Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.

Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S. || Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

Lot numbers: 0629293, 0626551, 0618233, 0612412, 0608207, 0605124, 0600214, 0585956, 0582479, 0576835, 0572250, 0565377, 0557560, 0551549, 0541635, 0540864, 0537157, 0533487, 0528683, 0524211, 0519856, 0516938, 0512528, 0510871, 0509707, 0506130, 0502530, 0502218, 0501931 and 0500756.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker, Sterile, catalog 804113, Terumo Cardiovascular Systems, Ann Arbor, MI. || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot number LK17

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: KC04, KD24, KE07, KH07, KK04, KN03, KP01, LA05, LC02, LC23, LD09, LG22, and LG22A.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in WI CARDIOVASCULAR PUMP & TABLE PACK (custom pack), catalog number 64789-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: KC11, KD24, KE14, and KF27.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-02, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: KG30, KK11, KN17, LA12, LC02, LD23, LF04, LG15, LG29, LK03, LL28, and MG01.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-03, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: MK23, MN29, and NC07.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-04, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: HM08R, HM08RT, and KE28.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog number 70579-04, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: KM13 and LK24.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog number 70579-05, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: KA14R, KC25, KD31, KE28, KF19, KG23, KK11, KK25, KM20, KN10, KP15, LA19, LC02, LC23, LD23, LE13, LF18, LG15, LH20, LK31, LL28, LL28T, LN02, LP21, MA18, MC15, MA18R, MD15, ME19, MF10, MH19, MK09, MK30, MM04, MN15, and NA03.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in X-COATED CUSTOM TUBING PACK, catalog number 70932-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.

Lot number MA04.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA. || The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: MD22, MK09, MK23, and NA03.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-02, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field.

Lot numbers: ME26, MG07, MH19, MK23, ML13, MM18, MN15, MP13, and NA24.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.

Sarns Flexible Weighted Sucker in X-COATED PUMP & TABLE PACK, catalog number 73067-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field.