Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX
This recall has been terminated (originally issued November 16, 2005).
- Company
- Medrad Inc
- Recall Initiated
- October 10, 2005
- Posted
- November 16, 2005
- Terminated
- August 15, 2007
- Recall Number
- Z-0154-06
- Quantity
- 4362 units
- Firm Location
- Indianola, PA
- Official Source
- View on FDA website ↗
Reason for Recall
the heat maintainer, an accessory, may overheat and deform the disposable syringe
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
Lot / Code Info
all serial numbers
Root Cause
Other
Action Taken
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.