Terumo Cardiovascular Systems Corporation: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti

Agency Publication Date: June 20, 2012

Affected Products

Product: SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 12315 and Lot codes: 0552019, 0557299, 0562142, 0572238, 0575869, 0579315, 0584831, 0590890, 0594622, 0598430, 0604045, 0612256, 0625339, 0640189, 0646473, 0652905, 0656574, 0666574, 0671713, and 593606C.

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Product: SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 12325 and Lot codes: 0551680, 0553010, 0557571, 0559882, 0562967, 0566831, 0569995, 0575870, 0579316, 0584969, 0589928, 0593454, 0595251, 0601331, 0606816, 0611597, 0617494, 0622167, 0626795, 0629156, 0632515, 0636330, 0640190, 0643858, 0649159, 0652241, 0656575, 0663510, and 621463C.

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Product: SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 12325X and Lot codes: 558946, 0589263, 0603353, 0640527, and 0653443.

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Product: SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 13010 and Lot codes: 0590855, 0593791, 0597307, 0603718, 0616892, 0624831,0629341,0634937, 0636270, 0644444, 0646144, 0653230, 0666586, and 0669487.

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Product: SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 13020 and Lot codes: 0550552, 0555854, 0557327, 0559103, 0562503, 0566861, 0570455, 0574279, 0577885, 0581606, 0585963, 0590856, 0593457, 0597308, 0605179, 0609199, 0614248, 0618969, 0626379, 0628950, 0634171, 0636332, 0640518, 0646396, 0653231, and 0666719.

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Product: SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 13030 and Lot code: 0553041, 0555967, 0557330, 0559885, 0562990, 0564951, 0567668, 0570456, 0571580, 0575365, 0580822, 0583186, 0585529, 0590858, 0593455, 0596125, 0600250, 0605504, 0609198, 0614183, 0620033, 0623325, 0626858, 0634096, 0636271, 0638011, 0640980, 0650900, 0653232, and 628985C.

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Product: SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 144776 and Lot code: 0552165, 0560615, 0574341, 0586004, 0606472, 0614321, 0617360, 0622689, 0637775, 0640519, and 0653855.

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Product: 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 88813030 and Lot code: 0550551, 0568495, 0576844, 0586459, 0601958, 0626874, and 0635682.

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Product: SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 64625 and Lot code: NA17, NC07A, NG06, NG06A, and NL19.

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Product: CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 80001-01 and Lot code: MG21, MM04, NA24, ND21, NK01, NM31, and PA30.

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Product: CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 80004-02 and Lot code: MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61742

Status: Resolved

Manufacturer: Terumo Cardiovascular Systems Corporation

Manufactured In: United States

Units Affected: 11 products (133,793 (each))

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers:

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Lot Numbers:

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Catalog number: 12325X and Lot codes: 558946, 0589263, 0603353, 0640527, and 0653443.

Lot Numbers:

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Catalog number: 13010 and Lot codes: 0590855, 0593791, 0597307, 0603718, 0616892, 0624831,0629341,0634937, 0636270, 0644444, 0646144, 0653230, 0666586, and 0669487.

Lot Numbers:

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Lot Numbers:

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Lot Numbers:

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Catalog number: 144776 and Lot code: 0552165, 0560615, 0574341, 0586004, 0606472, 0614321, 0617360, 0622689, 0637775, 0640519, and 0653855.

Lot Numbers:

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Product: 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 88813030 and Lot code: 0550551, 0568495, 0576844, 0586459, 0601958, 0626874, and 0635682.

Lot Numbers:

code

Product: SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 64625 and Lot code: NA17, NC07A, NG06, NG06A, and NL19.

Lot Numbers:

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Product: CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 80001-01 and Lot code: MG21, MM04, NA24, ND21, NK01, NM31, and PA30.

Lot Numbers:

code

Product: CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog number: 80004-02 and Lot code: MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23.

Lot Numbers:

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