Edwards Lifesciences Llc

Lot No.: 58832055, 58896850, 58916757

Cardiovascular Devices

2

No

Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.

Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.

Lot No.: 58803802, 58851054, 58881366

Cardiovascular Devices

2

No

Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.

Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614

Lot Number: 58946275

Cardiovascular Devices

2

No

Nationwide distribution: CA only.

Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Lot No.: 666556, 669235, 678238, 751043, 755821, 763122

Cardiovascular Devices

2

No

Nationwide Distribution

Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || The Steerable Coronary Sinus Catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters.

Lot No.: 718993, 718995, 718996, 718998, 718999, 719000, 719001, 739692, 739693, 742834, 742835, 747591, 751029, 751036, 751041, 755814, 755814A, 763115, 763119, 763123, 763125, 763127, 763128, 763129, 774333, 774334.

Cardiovascular Devices

2

No

Nationwide Distribution

EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614. || The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the EndoPlege coronary sinus catheter contamination guard, is packaged with these catheters