Z-0292-2007

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041

Name: Z-0292-2007 Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041
Creator: Terumo Cardiovascular Systems Corp
Published: 2005-10-06
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2005-10-06 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041 on 2005-10-06. The reason FDA records is "Six inch roller pumps were mislabeled as 4 inch roller pumps". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0292-2007
Status: Terminated
Initiated: 2005-10-06
Posted: 2007-01-09
Terminated: 2007-02-01
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Six inch roller pumps were mislabeled as 4 inch roller pumps.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.
Quantity in commerce: 2
Distribution: Worldwide-Michigan and Singapore.
Product codes and lots: Serial numbers 0976 and 0979.

Product code DTQ

K022947Class IIAdvanced Perfusion System 1 (100/120 Volt),advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 InchTerumo Cardiovascular Systems Corp. / cleared 2003-03-20

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)