Z-0238-2007

Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405

Name: Z-0238-2007 Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405
Creator: Terumo Cardiovascular Systems Corp
Published: 2006-09-14
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2006-09-14 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405 on 2006-09-14. The reason FDA records is "The hand crank handle may separate and detach from the unit during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0238-2007
Status: Terminated
Initiated: 2006-09-14
Posted: 2006-12-07
Terminated: 2008-06-19
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405.
Product code: DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Reason for recall: The hand crank handle may separate and detach from the unit during use.
FDA root cause: Other
Action: Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.
Quantity in commerce: 180
Distribution: Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Product codes and lots: Serial numbers 1126 through 1305.

Product code DTW

K915183Class IISarns 8000 Modular Perfusion System3M Health Care, Sarns / cleared 1992-07-08

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)