Z-1357-04

Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet, smooth balloon...

Name: Z-1357-04 Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet, smooth balloon...
Creator: Terumo Cardiovascular Systems Corp
Published: 2004-07-07
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2004-07-07 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corp began a recall of Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet, smooth balloon; catalog number 7271 on 2004-07-07. The reason FDA records is "The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed". 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-1357-04
Status: Terminated
Initiated: 2004-07-07
Posted: 2004-08-17
Terminated: 2004-10-26
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet, smooth balloon; catalog number 7271.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.
Distribution: United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales.
Product codes and lots: All lots.

Product code DWF

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)