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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Terumo perfusion

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  Class 2 Device Recall Sarns Terumo perfusion see related information
Date Initiated by Firm December 12, 2006
Date Posted March 14, 2007
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = 3M HEALTH CARE, SARNS
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