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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Perfusion System 8000

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  Class 2 Device Recall Terumo Perfusion System 8000 see related information
Date Initiated by Firm January 12, 2007
Date Posted March 27, 2007
Recall Status1 Terminated 3 on June 19, 2008
Recall Number Z-0659-2007
Recall Event ID 37366
510(K)Number K900815  
Product Classification Perfusion System - Product Code DTW
Product Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.
Code Information Hand crank serial numbers 1621 and 1622.
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		 The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
FDA Determined
Cause 2		 Other
Action Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.
Distribution Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
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 = DTW and Original Applicant = 3M COMPANY
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