Z-0367-2011

MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and...

Name: Z-0367-2011 MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and...
Creator: Medrad Inc
Published: 2010-05-17
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2010-05-17 / Terminated / root cause: packaging

FDA source

Medrad Inc began a recall of MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended... on 2010-05-17. The reason FDA records is "Some kits have a hole in the packaging which could compromise the sterility of the components". 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-0367-2011
Status: Terminated
Initiated: 2010-05-17
Posted: 2010-11-15
Terminated: 2010-11-17
Recalling firm: Medrad, Inc.
Product: MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Some kits have a hole in the packaging which could compromise the sterility of the components.
Root cause tag: packaging
FDA root cause: Packaging
Action: MEDRAD issued an URGENT MEDICAL DEVICE RECALL letter dated May 17, 2010, to all affected customers. The letter identified the product, the problem, and the action the customer should take. Customers were instructed to identify the product with the affected lot numbers. Contact MEDRAD Customer Support at 1-800-633-7231 to make arrangements for the return of the product. Complete and sign the form attached to the letter and fax it back to MEDRAD at 412-406-0942. For any questions regarding this recall call (412) 767-2400, ext 6851.
Quantity in commerce: 39,448 syringe kits
Distribution: Worldwide Distribution - USA including AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Belgium, China, Columbia, Germany, Denmark, France, Great Britain, Hungary, Ireland, India, Israel, Italy, Mexico, Netherlands, Sweden, and Singapore.
Product codes and lots: Lot Numbers 96501 exp 11/2014 and 96502 exp 11/2014

Product code DXT

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