Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. |
|---|---|
| Recall Number | Z-1832-2012 |
| Classification | Class II |
| Code Info | Catalog number: 12315 and Lot codes: 0552019, 0557299, 0562142, 0572238, 0575869, 0579315, 0584831, 0590890, 0594622, 0598430, 0604045, 0612256, 0625339, 0640189, 0646473, 0652905, 0656574, 0666574, 0671713, and 593606C. |
| Product Distributed Qty | 133,793 (each) |
| Reason For Recall | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. |
Event Detail
| Event Id | 61742 |
|---|---|
| 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 | 2012-05-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam. |
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