Terumo Cardiovascular Systems Corporation: During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. 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

Agency Publication Date: June 27, 2012

Affected Products

Product: Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 203861: 0548731, 0552411, 0556018, 0558941, 0563005, 0565138, 0565841, 0569745, 0570058, 0571163, 0571584, 0573043, 0573288, 0575518, 0580832, 0583446,0585251, 0586160, 0590448, 0591942, 0596210, 0600490, 0607020, 0618429, 0619201, 0630155, 0634777, 0640509, 0649185, 0652212, 0655898, 0661142, and 0668560.

Product: SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 203887 and lot numbers: 0551678, 0557083, 0561754, 0562984, 0568008, 0572137, 0575072, 0580833, 0583190,0586161,0591033,0596204, 0605323, 0612587, 0615536, 0619196, 0622171,0627245,0631928,0632342, 0639031,0641468,0648454,0650700, 0652249,0653439,0660677, and 593715C.

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Product: SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 203895 and lot numbers: 0551294, 0555085, 0557607, 0560171, 0563852, 0568020, 0572133, 0579089, 0586166, 0592735, 0598461, 0603720, 0611573, 0616893, 0619181, 0625003, 0633298, 0637811, 0640423, 0645344, 0649186, 0652248, 0655897, 0662813, and 621706C.

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Product: SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 203879 and lot numbers: 0558280, 0574328, 0590421, 0607092, 0613016, 0627693, 0641300, 0653436, 0655320, and 0666687.

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Product: FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 66015 and lot numbers: NC21, NF16, NL26, PA30,PC13, and PD05.

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Product: INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 71415-03 and lot numbers: NC21, NF16, NL26, PA30,PC13, and PD05.

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Product: XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 71415-04 and lot number: NN07

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Product: X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 71619 and lot number: ND14 and NE11.

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Product: X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 71936-01 and lot number: MH06, ML20, MN15, NG20, and NG20A.

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Catalog number: 71936-02 and lot number: PC06

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Product: MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 73395 and lot number: MK30 and MK30T

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Product: X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 74301 and lot number: PD19

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Product: X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 74302 and lot number: PD19

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Product: CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

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

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Product: CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 80001-02 and lot number: NP20 and PA16.

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Product: CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 80002-03 and lot number: MH12, MK30, MP06, NE18, NM31, and NN28.

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Product: CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 80003-02 and lot number: MH12, MK30, MP06, NA31, NE18, NF23, NM31, NN28, NP19, and PD05.

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Product: CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

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

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Catalog number: 80004-03 and lot number: NP20

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Product: CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Catalog number: 80004-03 and lot number: MG14, MK16, MN15, NC07, NE18, NK01, NM31, PA30, and PD05.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61731

Status: Resolved

Manufacturer: Terumo Cardiovascular Systems Corporation

Manufactured In: United States

Units Affected: 20 products (53,139 (each) in total)

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Sources: FDA iRES · Raw API Response

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Affected Products

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Catalog number: 203879 and lot numbers: 0558280, 0574328, 0590421, 0607092, 0613016, 0627693, 0641300, 0653436, 0655320, and 0666687.

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Catalog number: 66015 and lot numbers: NC21, NF16, NL26, PA30,PC13, and PD05.

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Catalog number: 71415-03 and lot numbers: NC21, NF16, NL26, PA30,PC13, and PD05.

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Catalog number: 71415-04 and lot number: NN07

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Catalog number: 71619 and lot number: ND14 and NE11.

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Catalog number: 71936-01 and lot number: MH06, ML20, MN15, NG20, and NG20A.

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Catalog number: 71936-02 and lot number: PC06

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Catalog number: 73395 and lot number: MK30 and MK30T

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Catalog number: 74301 and lot number: PD19

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Catalog number: 74302 and lot number: PD19

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

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Catalog number: 80001-02 and lot number: NP20 and PA16.

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Catalog number: 80002-03 and lot number: MH12, MK30, MP06, NE18, NM31, and NN28.

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Catalog number: 80003-02 and lot number: MH12, MK30, MP06, NA31, NE18, NF23, NM31, NN28, NP19, and PD05.

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

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Catalog number: 80004-03 and lot number: NP20

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Catalog number: 80004-03 and lot number: MG14, MK16, MN15, NC07, NE18, NK01, NM31, PA30, and PD05.

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