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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 Pump see related information
Date Initiated by Firm July 06, 2009
Date Posted December 17, 2009
Recall Status1 Terminated 3 on November 09, 2011
Recall Number Z-0544-2010
Recall Event ID 53577
510(K)Number K020998  
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Product 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.
Code Information Product Number 164275X, Serial Numbers: KP01, KP15, LA05, LA12, LA19, LC02, LC09, LC23, LD02, LD09, LD16, LD30, LE06, LE08, LE13, LE20, LE27, LE29, LF04 and LF07.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact Garry 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
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.
Quantity in Commerce 20,702 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KFM and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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