FDA (Devices) recall action 61742

Terumo Cardiovascular Systems Corporation recalled 11 products on 2012-06-27

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2012-06-27
Critical: 0
Units: 1,471,723

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–11 of 11

HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns Flexible Arterial Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connector surface can be dislodged during use.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that can be dislodged.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that could dislodge during use.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connectors can be dislodged during use.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that can be dislodged.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Kits Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulas because a foreign substance found on connectors can be dislodged during use.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.
Product
SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that could be dislodged.
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.
Category
Distribution
44 states
HighFDA (Devices)··2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Kits Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.
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.
Category
Distribution
44 states