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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Sarns high-flow aortic arch cannula		see related information
Date Posted January 11, 2013
Recall Number Z-0671-2013
Product Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface 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
Code Information Lot number: 0677299 and Catalog number: 12325X
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
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.
Action 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.
Quantity in Commerce 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).
 
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