Z-1192-03

Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog...

Name: Z-1192-03 Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog...
Creator: Terumo Cardiovascular Systems Corp
Published: 2003-08-08
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2003-08-08 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corp began a recall of Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 5578 on 2003-08-08. The reason FDA records is "Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility". 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-1192-03
Status: Terminated
Initiated: 2003-08-08
Posted: 2003-08-29
Terminated: 2004-03-11
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 5578
Product code: 74DWF
Reason for recall: Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Urgent device recall letters were sent to customers on August 8, 2003. Distributors were advised to notify their customers of this recall. Product is to be returned to Terumo.
Distribution: United States, Canada, Chile, China, Germany and Japan.
Product codes and lots: Lot 1197400

Product code 74DWF

K925442Class IISarns Retrograde Cannula3M Health Care, Sarns / cleared 1993-05-21

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)