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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Centrifugal Pump with XCoating

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  Class 2 Device Recall Sarns Centrifugal Pump with XCoating see related information
Date Initiated by Firm March 15, 2010
Date Posted September 28, 2010
Recall Status1 Terminated 3 on November 04, 2011
Recall Number Z-2606-2010
Recall Event ID 56322
510(K)Number K020998  
Product Classification Centrifugal Pump (Non-Roller Type) - Product Code KFM
Product Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 164275X.

CV-164275 is an item number for product that is sold to foreign affiliate.

Usage: The Sarns Centrifugal Pump (with X-Coating) is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures.
Code Information Pump manufacturing lots:  MA04 MA11 MA18 MA25 MC01 MC08 MC15 MC22 MD01 LM12 LM19 LN30 LN23 LP21 LM05 MD22 LP14A LP14 LP14AR MA04R LF04A LM26A LN02A MD29 ME05 MA11R MD15 LE13R LF04R LF11R LF18R LM26T LN02T LN09T LN16T LN23T LN30T LP07T LP14T LP21T MA04T MA11T MA11TA MA18A MA18R MA18T MA18TR MA25R MA25T MA25TA MC01T MC08T MC15T MC22T MD08 MD08T MD22T ME12 ME12T ME19 ME19T 
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Corporation
125 Blue Ball Road
Elkton MD 21921-5315
For Additional Information Contact Terumo Customer Service
800-521-2818
Manufacturer Reason
for Recall		 Medical device component may malfunction and require user intervention during surgical bypass procedures.
FDA Determined
Cause 2		 Other
Action The recalling firm notified end users, perfusion groups, and distributors by phone, fax, email and mail on 03/15/10 to advise of the required recall actions with instructions for labeling and returning the involved product from the customer level. The firm expanded their recall to include additional lots on 05/17/10. If you have any questions, please contact Customer Service at 800-521-2818.
Quantity in Commerce 28257 pumps
Distribution The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.
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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