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Terminated

Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).

FDA Recall Z-1005-2007 · Posted 2007-07-07

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2004-07-01
Date Terminated2007-12-12
Product Quantity728 pumps of all models

Reason for Recall

Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.

Firm Action

As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem

Root Cause

Other

Distribution Pattern

Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, and Viet Nam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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