—#108874

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.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K771499
Affected lot / code info: Catalog number: 13020 and Lot codes: 0550552, 0555854, 0557327, 0559103, 0562503, 0566861, 0570455, 0574279, 0577885, 0581606, 0585963, 0590856, 0593457, 0597308, 0605179, 0609199, 0614248, 0618969, 0626379, 0628950, 0634171, 0636332, 0640518, 0646396, 0653231, and 0666719.

Why it was 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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advises customers to discontinue use of the affected product and to return the product to the firm. A Response Form was attached for customers to complete and return. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam.

Timeline

Recall initiated: 2012-05-09
Posted by FDA: 2012-06-20
Terminated: 2013-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.