Z-0257-05

Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK

Name: Z-0257-05 Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
Creator: Medrad Inc
Published: 2004-11-03
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2004-11-03 / Terminated / root cause: packaging

FDA source

Medrad Inc began a recall of Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK on 2004-11-03. The reason FDA records is "Sterility can be compromised by a tear in the outer packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0257-05
Status: Terminated
Initiated: 2004-11-03
Posted: 2004-11-24
Terminated: 2005-04-20
Recalling firm: Medrad, Inc.
Product: Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Sterility can be compromised by a tear in the outer packaging.
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm issued recall letters dated 11/1/04 to their consignees informing them of the problem and the need to return the product.
Quantity in commerce: 875, 798 kits
Distribution: The product was shipped to distributors and medical facilities nationwide. The product was also shipped to Saudia Arabia, Kuwaitt, Maylasia, Israel, Chile, Hong Kong, Great Britain, Denmark, Germany, China, Canada, France, Taiwan, Thailand, Singapore, Finland, Phillipines, Norway, Netherlands,, Spain, Mexico, Czech, Japan, Italy, Sweden, Brazil, Belgium, and Austraila.
Product codes and lots: Lot Numbers 38821 through 45666 for each catalog number, Expiration Date October 2008.

Product code DXT

K023183Class IIMedrad Stellant CT Injector SystemMedrad, Inc. / cleared 2003-01-10

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)