FDA Device recall Z-1833-2012
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is in…
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is in… by Terumo Cardiovascular Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1833-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-09 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Reason
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 parti
Identifiers
| code_info | Catalog number: 12325 and Lot codes: 0551680, 0553010, 0557571, 0559882, 0562967, 0566831, 0569995, 0575870, 0579316, 0…Catalog number: 12325 and Lot codes: 0551680, 0553010, 0557571, 0559882, 0562967, 0566831, 0569995, 0575870, 0579316, 0584969, 0589928, 0593454, 0595251, 0601331, 0606816, 0611597, 0617494, 0622167, 0626795, 0629156, 0632515, 0636330, 0640190, 0643858, 0649159, 0652241, 0656575, 0663510, and 621463C. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1833-2012%22
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