Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with sin
FDA device recall Z-0544-2010 · posted 2009-12-17 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 20,702 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-07-06
- Date posted
- 2009-12-17
- Date terminated
- 2011-11-09
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X (K020998) | Terumo Cardiovascular Systems Corp. | 2002-04-04 |