RecallDepth

Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.

Company
Terumo Cardiovascular Systems Corp
Recall Initiated
April 1, 2004
Posted
June 30, 2007
Terminated
June 11, 2008
Recall Number
Z-0923-2007
Quantity
525 total for both models
Firm Location
Ann Arbor, MI

Reason for Recall

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

Distribution

Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.

Lot / Code Info

Serial numbers 0031 through 0324 are potentially affected by the problem. Serial numbers 0092, 0128, 0152, 0223, 0226, 0237, 0246, 0260 and 0296 have been corrected.

Root Cause

Other

Action Taken

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.

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