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U.S. Department of Health and Human Services

Class 3 Device Recall Terumo APS 1

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 Class 3 Device Recall Terumo APS 1see related information
Date Initiated by FirmAugust 01, 2005
Date PostedJune 30, 2007
Recall Status1 Terminated 3 on February 23, 2008
Recall NumberZ-0932-2007
Recall Event ID 37242
Product Classification Perfusion System - Product Code DTQ
ProductTerumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
Code Information Serial number range of 0031 through 1141 may be affected by this problem.
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 tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing.
FDA Determined
Cause 2		Other
ActionThe firm is visiting the consignees as complaints are received and making corrections. Corrections were made in August 2005 and April 2006 to date. Other units will be repaired if complaints are received and the firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and appropriate action to take should it occur.
Quantity in Commerce1982 total for both models distributed
DistributionWorldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, 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.
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