Terumo Cardiovascular Systems Corporation

Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K

General and Plastic Surgery Devices

2

No

USA Nationwide Distribution in the state of LA, NJ, and NY.

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** || Product Usage: || The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.

Cardiovascular Devices

2

No

Nationwide Canada

Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line

Recalled filters sold singly are identified with Part Number AL6X with the following lot codes:  MM19,  MN23,  NC15,  ND01,  ND08,  ND29,  NE11,  NE18,  NE25,  NF09,  NF31,  PA23,  PD05,  PE02,  PF14,  PF21,  PG04,  PG11,  PG18,  PG25,  PH09,  PH16,  PH30,  PK06,  PK13,  PL24,  PM01,  PM08,  PM22,  PM29,  PN12,  PN26,  PP17,  PP31,  QA07,  QA14,  QA21,  QC04,  QC25,  QD11,  QD18,  QD25,  QE08,  QE15,  QE22,  QE29,  QF06,  QF28, MM26,  NL12,  NM24,  NP12, and PA30;    Affected filters, also Part # AL6X, packaged within Terumo Cardiovascular Convenience Kits are identified with the following lot codes:  PN19,  QA14,  QC11R,  QD04,  QE15,  QF06,  QF13,  NM31,  NP05,  PC20,  PD05,  QF28,  QC04,  PD26,  PG04,  PE23R,  PK13,  PK20,  QA21,  QC11,  QC11A,  QD11,  QE01,  PL17,  QE08,  NK08,  PG25,  PN26,  QC18,  NN07,  NN07R,  PA16,  PA16R,  PC27,  PC27R,  PF07,  PL24,  PD12,  PE09,  PE30,  PH09,  PL10,  PE23,  PF14,  PG18,  PK06,  PM01,  PM22,  PN12,  QA02,  QA28,  QC25,  QD25,  NK01,  NK08R,  PH23,  PH16,  PL10A,  PM15,  PP10,  PP17,  QD18,  QE22,  NM17,  NM17A,  PC06,  PC06R,  PE09R,  QE01A,  QE15A,  QE15T,  QE15TA,  QE15TC,  QF13T,  QF20,  QF20T,  NA10R,  NA17R,  ND14,  ND28,  ND28T,  NE11T,  NE18,  NF23,  NG06,  NG20,  NH11,  NH18,  NK15,  NL12,  NL26,  NM03,  NM10,  NM24,  NN14,  NN28,  NP12,  PA30,  PC13,  PD19,  PE16,  PF07A,  PF21,  PK27,  PK27A,  PL04,  PM08,  PP03,  QA14T,  QE29,  QF28T,  QF28TA,  PG11,  PH30,  PH30A,  PN26A,  QA07,  NH25,  NK29,  PE02,  PF29,  PN19,  QG17,  PK13A,  QD11A,  MN22,  NE25,  NF31,  PM29,  PA09,  QG03,  PA02,  PH23T,  PG11T,  QC18R,  QF06A,  PH09T,  PH09TA,  QF13TA,  QF20TA, and QF20TC

Cardiovascular Devices

2

No

Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV.

Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit || Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.

Pack Lot Nos. RA27T, RA20, RA06T, QP09A, QN18A, RA06A, QP16A, RA20A, RC03A, and RC17T.   QM21, RA27, RA27R, QN07, QM28, QF13A, QM21, QN25, QP16, QM14, QN18, QN11, QN04, RA13, QF06R, RC10, QM14T, QM21A, RC24, QF06, QP09, QF20A, QF13R, QF06RT, QG03RA, QG17, QL03, QM14T, QN25A, QE29, QE29T, QL16, QM28A, QM28C, QM28T, QK05, QK05AC, QK26, QK26A, QL02, QL16, QL16A, QL23, QN11A, QF20, QH08, QP02A, QP16, RC03, RA02, RA06, RC24, QK26, QE15, QM21T, QP02A, RA27A, QM07, QL02, QH08, QN25, QG17, QF06, QF06T, QF13, QF13T, QF13TA, QN18, QA21R, QE29T, QF28, RC03, QF28, RC17, QF06, RA13, QF20, QL03, RA27A, QH22, QG10, and RC24.

Cardiovascular Devices

2

No

Nationwide Distribution

Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. || Catalog numbers || 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 74466, 71317-02 72991-02, 74951, 74336, 74121-01, 72941-01, 73315-03, 74559, 74277, 71382-01, 73108-02, 74178-03, 71598-02, 73108-02, 74618-01, 70334-03, 74802-01, 74916, 71932-02, 70951-03, 73957-01, 74857-01, 70957-02, 73449-01, 73124, 71546-02, 72892-01, 74431, 72370, 73913-01, 73957-01, 75028, 71820-01, 74201, 74402, 73891-01, 73865, 73972, 71175-01, 73208-03, 72669-02, 70533-09, 72275-01, 74369, 74321-01, 73175, B73235, 74459, 73931, 74262-01, 71002-01, 74879-01, 71801-01, 72384, 74365, 74366, 74348-01, 72072-02, 74048, 70932-03, 73407, 74879-01, 73820-01, 74161-01, 72991-02, 73288-01, 70016, 70466-08, 70188-04, 72238-02, 72817-01, 71103-02, 71717-01, 70957-02, 70196-02, 73872-02, 71896-02, 73191-01, 70977-05, 73438, 73201-01, 74671, 70367-07, 73276-02, 74482-01, 73551-02, 71537, 74348-01, 73211-01, 74430, 72026-03, 74502, 74873, 73652-01, 74163-02, 71733-02, 70075-06, 72846, 73820-01, 75063, 74155-01, 74454-01, 73428-01, 73442-01, 70664-01, 70012-05, 70099-03, 70159-05, 70917, 72965-02, 73645-01, 74417, 73346, 74433, 74737, 73055-02, 70227-04, 70880-05, 71934-02, 72073-01, 72149-01, 74120-01, 72370, 73662-03, 74251, 73872-02, 70658-09, 74550, 74124, 74096-01, 74203, 70174-09, 71485-01, 71905-01, 73124, 73874, 74467-01, 8327TXC-08, 8365TXC-01, 8390TXC, 74433, and 74737. || For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures.

Lot No. RC07, QM03, QN07, and RA09.

Cardiovascular Devices

2

No

Nationwide Distribution

Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. || For use in cardiopulmonary bypass procedures.