Terumo Cardiovascular Systems Corporation Recall: Sarns flexible arterial cannula, 8.0 mm
Terumo Cardiovascular Systems Corporation Recall: Sarns flexible arterial cannula, 8.0 mm is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Terumo Cardiovascular Systems Corporation; Product: Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm)
| Recalling firm | Terumo Cardiovascular Systems Corporation |
|---|---|
| Product | 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 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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 |
| Recall initiated | 20130107 |
| Recall number | Z-0668-2013 |
| Category | device |
| State | MI |
| Country | United States |
$29/mo
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