PlainRecalls
FDA Devices Moderate Class II Terminated

Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Reported: January 23, 2013 Initiated: January 7, 2013 #Z-0670-2013

Product Description

Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Reason for Recall

Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.

Details

Units Affected
6830 total all products
Distribution
Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).
Location
Ann Arbor, MI

Frequently Asked Questions

What product was recalled? ▼
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 6830 total all products.
Why was this product recalled? ▼
Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 23, 2013. Severity: Moderate. Recall number: Z-0670-2013.

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