Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.
Recall
- Recall Number
- Z-0545-2010
- Event Number
- 53577
- Firm
- Terumo Cardiovascular Systems Corporation
- FEI Number
- 1828100
- Product Code
- KFM
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 6, 2009
- Posted
- December 17, 2009
- Terminated
- November 9, 2011
- Address
- 6200 Jackson Road, Ann Arbor, MI, 48103-9586
Description
Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.
The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
Terumo Cardiovascular Systems Corporation notified consignees of an "Urgent Medical Device Correction" by letter on July 06, 2009. The letter was addressed to hospital Perfusion, Cardiovascular Surgery, and Operating Room departments and contained specific measures to be taken to ensure proper use of the affected device. The firm recommended that users continue to use the devices and follow the corrective measures enclosed with the notification. Consignees were requested to route the notification to all users and confirm receipt of the notification by returning a customer response form. For further information, contact Terumo CVS Customer Service at 1-800-521-2818.
Nationwide Distribution
13,753 units