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 for use in cardiopulmonary bypass procedures.
Recall
- Recall Number
- Z-2606-2010
- Event Number
- 56322
- Firm
- Terumo Cardiovascular Corporation
- FEI Number
- 3000204839
- Product Code
- KFM
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 15, 2010
- Posted
- September 28, 2010
- Terminated
- November 4, 2011
- Address
- 125 Blue Ball Road, Elkton, MD, 21921-5315
Description
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 for use in cardiopulmonary bypass procedures.
Medical device component may malfunction and require user intervention during surgical bypass procedures.
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.
The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.
28257 pumps