Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
FDA Recall Z-0931-2007 · Posted 2007-06-30
Advertisement
Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2005-08-01
Date Terminated2008-02-23
Product Quantity1982 total for both models
Reason for Recall
The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing.
Firm Action
The firm is visiting the consignees as complaints are received and making corrections. Corrections were made in August 2005 and April 2006 to date. Other units will be repaired if complaints are received and the firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and appropriate action to take should it occur.
Root Cause
Other
Distribution Pattern
Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, 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.
Advertisement