Recall Z-2606-2010 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Terumo Cardiovascular Corporation
Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 164275X. CV-164275 is an item number for product that is sold to foreign affiliate. Usage: The Sarns Centrifugal Pump (with X-Coating) is indicated as an extracorporeal blood pump f
| Date | Sep 28, 2010 (initiated Mar 15, 2010) |
| Status | Terminated |
| Reason | Medical device component may malfunction and require user intervention during surgical bypass procedures. |
| Root cause | Other |
| Action | The recalling firm notified end users, perfusion groups, and distributors by phone, fax, email and mail on 03/15/10 to advise of the required recall actions with instructions for labeling and returning the involved product from the customer level. The firm expanded their recall to include additional lots on 05/17/10. If you have any questions, please contact Customer Service at 800-521-2818. |
| Quantity | 28257 pumps |
| Distribution | The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020998 | SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X Terumo Cardiovascular Systems Corp., Apr 4, 2002 |