Terumo Cardiovascular Systems Corporation

6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution.

CDI¿ H/S Cuvette || The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

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

TAOS, TC03

Cardiovascular Devices

2

No

Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall

The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.

SAFETY ALERT Lot Codes:  (a) RH14, RK11, RK20, RL02, RM06, RM20, RN10, RP08, TD16, TE13, TE27, TF14, TF21, TG04, TG11, TG17, TH06, TH16, TK10, TK24, TL08, TL21, TM28, TP14, UA11, UA18, UA25, UC08, UC22, UD14, UD21, UD28, UE05, UE18, UF09, UG06, UK01, UL12, UM10, UM31, UP05, VA02, VC06, VD06, VE10    (b) RH14, RH21, RK18, RL15, RM01, RM22, RN24, RP01, TA19, TF05, TF27, TG19, TH20, TK24, TL01, TM12, TN09, TP03, UA20, UC15, UD22, UE04, UE18, UF02, UG13, UH11, UK15, UL06, UM10, VA02, VA30, VC27, VE03, VF01   LH130 PRODUCT CORRECTION lot codes or serial number range: TA19 through VD06, distribution date range: 08Apr2015 through 20Jan2017

Cardiovascular Devices

2

No

Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan

TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J