Z-2149-2010

Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937

Name: Z-2149-2010 Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937
Creator: Terumo Cardiovascular Systems Corp
Published: 2010-06-08
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2010-06-08 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937 on 2010-06-08. The reason FDA records is "Vent port may be occluded and prevent delivery of fluid". 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-2149-2010
Status: Terminated
Initiated: 2010-06-08
Posted: 2010-08-02
Terminated: 2012-05-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: Vent port may be occluded and prevent delivery of fluid
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
Quantity in commerce: 17 packs
Distribution: Distribution USA and Canada
Product codes and lots: Lot: ME05

Product code DTR

K823451Class IIClear Cardioplejia Delivery System3M Health Care, Sarns / cleared 1983-01-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)