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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-0656-2007
Recall Event ID 37366
510(K)Number K900815  
Product Classification Perfusion System - Product Code DTW
Product Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.
Code Information Hand crank serial numbers 1963 through 1986.
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.
Quantity in Commerce 36
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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