Z-1228-2009

MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of...

Name: Z-1228-2009 MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of...
Creator: Medrad Inc
Published: 2009-01-29
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2009-01-29 / Terminated / root cause: packaging

FDA source

Medrad Inc began a recall of MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media on 2009-01-29. The reason FDA records is "Possible compromised sterility due to holes in styrene tray". 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-1228-2009
Status: Terminated
Initiated: 2009-01-29
Posted: 2009-06-01
Terminated: 2009-06-04
Recalling firm: Medrad, Inc.
Product: MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Possible compromised sterility due to holes in styrene tray
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 1/29/09, Medrad issued an Urgent Medical Device Recall letter. Customers were requested to check their inventory for any of the affected batch. If the customer has affected product, they are instructed to contact the firm to make arrangement for the return of the product. Non responders were sent additional notifications via FedEx on 3/2/09 and 4/1/09.
Quantity in commerce: 2958 kits
Distribution: Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.
Product codes and lots: catalog number DSK 130-Q. Lot number 72372

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)