Terumo Cardiovascular Systems Corporation: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow¿ Aortic Cannulae and Sarns" Venous Return Cannulae.

Agency Publication Date: November 8, 2013

Affected Products

Product: Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog Number 5762 Lot Numbers 0677300

Lot Numbers:

Numbers

Product: Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog Number 5798 Lot Numbers 0677301

Lot Numbers:

Numbers

Product: Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Catalog Number 5841 Lot Numbers 0677302

Lot Numbers:

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Product: Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.

Catalog Number 9473 Lot Numbers 0689812

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66624

Status: Resolved

Manufacturer: Terumo Cardiovascular Systems Corporation

Manufactured In: United States

Units Affected: 4 products (90 units; 70 units; 30 units; 40 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Catalog Number 5762 Lot Numbers 0677300

Lot Numbers:

Numbers

Catalog Number 5798 Lot Numbers 0677301

Lot Numbers:

Numbers

Catalog Number 5841 Lot Numbers 0677302

Lot Numbers:

Numbers

Catalog Number 9473 Lot Numbers 0689812

Lot Numbers:

Numbers