Enforcement Report - Week of January 23, 2013
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Product Detail
| Product Description | Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (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 |
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| Recall Number | Z-0668-2013 |
| Classification | Class II |
| Code Info | Lot number: 067728 and 0681074 and Catalog number: 13030 |
| Product Distributed Qty | 6830 total 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). |
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