Z-0664-03

Sarns MP4 Cardioplegia Sets; catalog number 15501

Name: Z-0664-03 Sarns MP4 Cardioplegia Sets; catalog number 15501
Creator: Terumo Cardiovascular Systems Corp
Published: 2003-02-25
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2003-02-25 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Sarns MP4 Cardioplegia Sets; catalog number 15501 on 2003-02-25. The reason FDA records is "There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0664-03
Status: Terminated
Initiated: 2003-02-25
Posted: 2003-03-20
Terminated: 2003-06-06
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns MP4 Cardioplegia Sets; catalog number 15501.
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
FDA root cause: Other
Action: Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers.
Quantity in commerce: 300
Distribution: United States
Product codes and lots: Lot 322125

Product code DTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)