Sarns Centrifugal Pump (with X-coating), catalog 164275X, 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.
FDA Recall Z-0544-2010 · Posted 2009-12-17
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeKFM
Date Initiated2009-07-06
Date Terminated2011-11-09
Product Quantity20,702 units
Reason for Recall
The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
Firm 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 further information, contact Terumo CVS Customer Service at 1-800-521-2818.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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