Class 2 Device Recall Terumo APS1

• Date Initiated by Firm: November 10, 2006
• Date Posted: December 27, 2006
• Recall Status: Terminated on June 19, 2008
• Recall Number: Z-0307-2007
• Recall Event ID: 36349
• Product Classification: cardiovascular perfusion system - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).
• Code Information: All units Serial numbers 0006 through 0213.
• 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: Other
• Action: A 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 Commerce: 208
• Distribution: Worldwide, 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 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.