Class 2 Device Recall Sarns Terumo perfusion

• Date Initiated by Firm: December 12, 2006
• Date Posted: March 14, 2007
• Recall Status: Terminated on June 19, 2008
• Recall Number: Z-0617-2007
• Recall Event ID: 36962
• 510(K)Number: K882758
• Product Classification: perfusion system - Product Code KFM
• Product: Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
• Code Information: Serial numbers 0001 through 2696.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
• FDA Determined Cause: Other
• Action: Consignees will be notified via letter dated 12/12/06, which provides instructions for identifying defective manual drives and to contact the firm if their unit is defective.
• Quantity in Commerce: 2696
• Distribution: Woldwide, including USA, Canada, and Mexico
• 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