Recalls / —

—#115297

Product

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

FDA product code

DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K083301, K770429, K771499

Affected lot / code info

Lot number: 0680122, 0680751and Catalog number: 12325

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

TERUMO sent an URGENT MEDICAL DEVICE RECALL notification to all consignees on January 7, 2013. Terumo CVS is advising users to discontinue use and return all affected cannulae in inventory. Terumo CVS will issue credit for returned cannulae. Terumo CVS providied a list of marketed devices that can be used as alternatives. Contact Terumo CVS Customer Service with questions or concerns: 800- 521- 2818 Monday Friday, 8 AM - 6 PM EST For questions regarding this recall call 734-741-6173.

Recalling firm

Firm

Terumo Cardiovascular Systems Corporation

Address

6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern

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).

Timeline

Recall initiated

2013-01-07

Posted by FDA

2013-01-11

Terminated

2013-08-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #115297. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.