Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial per

FDA device recall Z-2449-2012 · posted 2012-09-25 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat

Action taken

TERUMO sent an Urgent Medical Device Recall letter dated September 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Medical Device Recall notice; assure that all users are aware of the notice; and confirm receipt of the communication by faxing the attached Customerr Resonse Form to 1-734-741-6149. Terumo CVS will send a representative to each affected US account to replace the affected devices and return the affected devices to Terumo for destruction. Non-US Terumo Affiliates will be instructed to remove the devices from the field and provide a record of destruction. For question customers should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Root cause

Process control

Status

Terminated

Product code

DTQ

Quantity affected

72 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.

Date initiated

2012-09-20

Date posted

2012-09-25

Date terminated

2014-01-13

Location

Ann Arbor, MI

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