Recall Z-0154-06 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX
| Date | Nov 16, 2005 (initiated Oct 10, 2005) |
| Status | Terminated |
| Reason | the heat maintainer, an accessory, may overheat and deform the disposable syringe |
| Root cause | Other |
| Action | 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. |
| Quantity | 4362 units |
| 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, Taiw |
| FDA record | Open on fda.gov |