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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Product Detail

Product Description Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 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
Recall Number Z-0666-2013
Classification Class II
Code Info Lot number: 0677286 and Catalog number: 13010.
Product Distributed Qty 6830 total units for all products
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.

Event Detail

Event Id 64007
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-07
Initial Firm Notification of Consignee or Public Letter
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).