Terumo Advanced Perfusion System 1, 4 inch diameter (small) Roller Pump; Model 801040.
FDA Recall Z-0600-2007 · Posted 2007-06-30
Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2004-09-01
Date Terminated2009-07-07
Product Quantity1,484 of both models
Reason for Recall
The internal ribbon cable may loosen from the roller pump display board, resulting in loss of local control and/or local display.
Firm Action
The firm corrected units in the field or brought them back for evaluation and repair as complaints were received between 9/04 and 4/06. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.
Root Cause
Other
Distribution Pattern
Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Mexico, Malaysia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.