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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS1

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 Class 2 Device Recall Terumo APS1see related information
Date Initiated by FirmNovember 10, 2006
Date PostedDecember 27, 2006
Recall Status1 Terminated 3 on June 19, 2008
Recall NumberZ-0306-2007
Recall Event ID 36349
510(K)NumberK022947 
Product Classification cardiovascular perfusion system - Product Code DTQ
ProductTerumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.
Code Information All units. Serial numbers 0011 through 0499.
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		Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
FDA Determined
Cause 2		Other
ActionA letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.
Quantity in Commerce488
DistributionWorldwide, including USA, 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 = DTQ
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