Z-0147-2012

Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe...

Name: Z-0147-2012 Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe...
Creator: Medrad Inc
Published: 2011-10-24
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2011-10-24 / Terminated / root cause: packaging

FDA source

Medrad Inc began a recall of Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of... on 2011-10-24. The reason FDA records is "Packaging may exhibit open seals - sterility compromised". 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-0147-2012
Status: Terminated
Initiated: 2011-10-24
Posted: 2011-11-02
Terminated: 2016-10-24
Recalling firm: Medrad, Inc.
Product: Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Packaging may exhibit open seals - sterility compromised
Root cause tag: packaging
FDA root cause: Packaging
Action: Medrad sent a " Urgent Medical Device Recall letter" dated October 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed if they have any of the affected product lot, please contact MEDRAD customer support to make arrangements for the return of the product. Call 1 -800-633-7231, select option 5, then select option 1. Indicate that you are calling about the affected syringe kit recall. Complete and sign the attached response form and fax it back to MEDRAD at (412) 406-0942. Please complete and fax this form even if you do not have any of the referenced product so we can maintain proper accountability for all syring kits that have been shipped.
Quantity in commerce: 17,380
Distribution: Nationwide Distribution -- including the States of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, VS, WA, WV, and WI.
Product codes and lots: Catalog # SDS-CTP-SPK, Lot # 112865

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)