Skip to content

Stellant Dual Syringe Kits. CT Injector and Accessories.… recallZ-0257-05 · Medrad Inc · initiated Nov 3, 2004

Terminated All recalls posted in November 2004

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medrad Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Sterility can be compromised by a tear in the outer packaging.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0257-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 3, 2004
Posted by the FDA
Nov 24, 2004
Recalling firm
Medrad Inc
Quantity
875, 798 kits
Product code
DXT
FDA submissions
K023183
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 description

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

Code information (models, lots, serial numbers)

Lot Numbers 38821 through 45666 for each catalog number, Expiration Date October 2008.

Other devices under the same FDA submission

15 devices cleared under K023183 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page