Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406.
FDA Recall Z-0658-2007 · Posted 2007-03-27
Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTW
Date Initiated2007-01-12
Date Terminated2008-06-19
Product Quantity18
Reason for Recall
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
Firm Action
Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan 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.