Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns(TM) or similar equipment.
FDA Recall Z-0309-2009 · Posted 2008-11-25
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2008-07-18
Date Terminated2009-07-07
Product Quantity1119
Reason for Recall
The pumps may fail to power up or experience unplanned pump stops.
Firm Action
Consignees were advised of the problem via an Urgent Medical Device Correction: Safety Advisory letter dated 7/18/08 and each consignee was contacted by phone to assure receipt. The letter noted that the firm was not recommending that customers stop using the product. If customers found the risk unacceptable they were to contact Technical Service, 1-800-521-2818. Customers were to review the notice, assure all users were aware of the notice, and confirm receipt by completing the attached Customer Response Form and faxing it to the number indicated on the form.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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