Z-1954-2010

Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK

Name: Z-1954-2010 Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
Creator: Medrad Inc
Published: 2010-05-24
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2010-05-24 / Terminated

FDA source

Medrad Inc began a recall of Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK on 2010-05-24. The reason FDA records is "Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1954-2010
Status: Terminated
Initiated: 2010-05-24
Posted: 2010-07-09
Terminated: 2010-10-13
Recalling firm: Medrad, Inc.
Product: Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.
FDA root cause: Other
Action: The recalling firm issued an Urgent Medical Device Field Correction on 5/24/10 requesting customers to check their inventory for the affected lots and complete the fax back form with the amount of product in stock. The manufacturer plans to make arrangements to provide individually packaged low-pressure connector tubing to use with the product in the event that cracking or breaking and leaking of the T connector is observed. This requires vigilance by the customers over the life of all of the devices. For questions concerning this recall, please contact the company 1-800-633-7231, select option 2, and indicate that you are calling about the Stellant CT Dual Syringe Kit field correction.
Quantity in commerce: 1,382,889 kits
Distribution: nationwide and Worldwide distribution includes AU, BE, BG, BM, BR, CA, CH, CI, CL, CN, CO, CS, DE, DK, EC, EG, FI, FR, GB, GT, HN, IN, IT, JM, JP, KW, KY, MU, MX, MY, NL, OM, PA, PH, PK, PR, SE, SG, TW, YE, ZA.
Product codes and lots: 99725, 99726, 99727, 99728, 99729, 99730, 99731, 99733, 99734, 99747, 99748, 99749, 99750, 99753, 99754, 99755, 99757, 99766, 99767, 99768, 99772, 99775, 99776, 99777, 99778, 99813, 100053, 100464, 100465, 100466, 100467, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100478, 100479, 100488, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100520, 100521, 100523, 100524, 100525, 100526, 100528, 100529, 100531, 100532, 100533, 100535, 100537, 100538, 100539, 100541, 100542, 100543, 100546, 100547, 100549, 100550, 100551, 100552, 100553, 100555, 100558, 100559, 100560, 100561, 100564, 100567, 100568, 100569, 100570, 100897, 101378, 101379, 101380, 101386, 101387, 101391, 101394 with exp dates between 2/2014 to 4/2014.

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