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.
FDA Recall Z-2606-2010 · Posted 2010-09-28
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Recalling FirmTerumo Cardiovascular Corporation
Recall StatusTerminated
Product CodeKFM
Date Initiated2010-03-15
Date Terminated2011-11-04
Product Quantity28257 pumps
Reason for Recall
Medical device component may malfunction and require user intervention during surgical bypass procedures.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.
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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