Recall Z-1841-2012— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2012-05-09, terminated 2013-07-11. It names one FDA 510(k) clearance: K770429. Product: CUSTOM CPB CATHETER KIT-DR. 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.
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-09
- Terminated
- 2013-07-11
- Firm location
- Ann Arbor, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
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 parti
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