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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Centrifugal Pump

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 Class 2 Device Recall Sarns Centrifugal Pumpsee related information
Date Initiated by FirmJuly 06, 2009
Date PostedDecember 17, 2009
Recall Status1 Terminated 3 on November 09, 2011
Recall NumberZ-0545-2010
Recall Event ID 53577
510(K)NumberK915363 
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
ProductSarns 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.
Code Information Product Number: 164275, Serial Numbers: KN10, KN26, KP08, LA05, LA12, LA19, LA22, LA26, LC12, LC16, LD16, LD23, LE01, LE15, LE22, LE29 and LF07.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information ContactGarry Courtney
800-283-7866 Ext. 7420
Manufacturer Reason
for Recall		The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
FDA Determined
Cause 2		Device Design
ActionTerumo 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.
Quantity in Commerce13,753 units
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KFM
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