Z-0658-2007

Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406

Name: Z-0658-2007 Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406
Creator: Terumo Cardiovascular Systems Corp
Published: 2007-01-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2007-01-12 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406 on 2007-01-12. The reason FDA records is "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.)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0658-2007
Status: Terminated
Initiated: 2007-01-12
Posted: 2007-03-27
Terminated: 2008-06-19
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406.
Product code: DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
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.)
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.
Quantity in commerce: 18
Distribution: Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
Product codes and lots: Hand crank serial numbers 1197 through 1214.

Product code DTW

K900815Class IISarns 9000 Perfusion System W/alert Only Level3M Company / cleared 1990-05-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)