| | Class 2 Recall
Sarns flexible arterial cannula |  |
| Date Posted |
January 11, 2013 |
| Recall Number |
Z-0668-2013 |
| 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 |
| Code Information |
Lot number: 0677287 and 0681074 and Catalog number: 13030
|
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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