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Stellant CT Injection System. Powered Injector with… recallZ-0154-06 · Medrad Inc · initiated Oct 10, 2005

Terminated All recalls posted in November 2005

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

the heat maintainer, an accessory, may overheat and deform the disposable syringe

FDA root cause category: Other

What the company is doing

The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/12/05 via certified mail. The notice provided instructions to apply warning labels and disconnect the heat maintainer until a field upgrade kit is available. In case where the heat maintainer is a necessity for specific procedures, the customer is being instructed to observe certain precautions.

Recall details

Recall number
Z-0154-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 10, 2005
Posted by the FDA
Nov 16, 2005
Recalling firm
Medrad Inc
Quantity
4362 units
Product code
DXT
FDA submissions
K023183, K033881
Distribution
The products were shipped to medical facilities nationwide. The products were also shipped to Canada, Isreal, Italy, Denmark, Netherlands, Norway, Great Britain, France, Poland, Germany, Spain, Finland, Belgium, Sweden, Russia, Austraila, Cuba, Mexico, Peru, Hong Kong, Korea, Mylasia, Thialand, Taiwan, Singapore, India, China, Turkey, Saudia Arabia, and Japan

Product description

Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX

Code information (models, lots, serial numbers)

all serial numbers

Other devices under the same FDA submission

15 devices cleared under K023183, K033881 — 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

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