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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo perfusion

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 Class 2 Device Recall Terumo perfusionsee related information
Date Initiated by FirmSeptember 14, 2006
Date PostedDecember 07, 2006
Recall Status1 Terminated 3 on June 19, 2008
Recall NumberZ-0235-2007
Recall Event ID 36150
510(K)NumberK900815 
Product Classification Perfusion system - Product Code DTW
ProductTerumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300.
Code Information Serial numbers 5331, 5332, 5333, 5334, 5337, 5339, 5340, 5341, 5342, 5343, 5344, 5346, 5347, 5350, 5356, 5362, 5368, 5369, 5370, 5378, 5383, 5384, 5389, 5396, 5397, 5398, 5400, 5409, 5411, 5412, 5413, 5415, 5416, 5418, 5419, 5420, 5421, 5423, 5424, 5425, 5430, 5433, 5434, 5436, 5437, 5439, 5441, 5442, 5444, 5445, 5446, 5451, 5454, 5455, 5456, 5457, 5458, 5459, 5460, 5461 and 5462.
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 handle may separate and detach from the unit during use.
FDA Determined
Cause 2		Other
ActionConsignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.
Quantity in Commerce61
DistributionWorldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTW
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