Recall Z-1841-2012 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
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.
| Date | Jun 20, 2012 (initiated May 9, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advises customers to discontinue use of the affected product and to return the product to the firm. A Response Form was attached for customers to complete and return. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall. |
| Quantity | 133,793 (each) |
| Distribution | 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 co |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K770429 | CANNULAE, AORTIC, ARCH, HIGH FLOW 3M Health Care, Sarns, Mar 16, 1977 |