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Terminated

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

FDA Recall Z-0924-2007 · Posted 2007-06-30

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2004-04-01
Date Terminated2008-06-11
Product Quantity525 total for both models

Reason for Recall

A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.

Firm Action

The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur.

Root Cause

Other

Distribution Pattern

Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore 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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