Recall Z-0545-2010 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Terumo Cardiovascular Systems Corporation
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.
| Date | Dec 17, 2009 (initiated Jul 6, 2009) |
| Status | Terminated |
| Reason | The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss. |
| Root cause | Device Design |
| Action | 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 f |
| Quantity | 13,753 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915363 | SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) 3M Health Care, Ltd., Jul 28, 1993 |