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Terminated

Terumo Advanced Perfusion System 1 Roller Pump 4 inch diameter; Catalog No. 801040.

FDA Recall Z-1404-06 · Posted 2006-08-22

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2006-06-30
Date Terminated2008-06-19
Product QuantityRecall Numbers Z-1403-1405-2006 -1,135 systems in the U.S. plus 723 internationally.

Reason for Recall

The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.

Firm Action

The firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06.

Root Cause

Other

Distribution Pattern

Worldwide-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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022947ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCHTerumo Cardiovascular Systems Corp. · 2003-03-20

Official Source

View FDA Recall →

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

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