FDA Recall
Terminated
IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
Recall: Z-0351-06
·
Initiated November 7, 2005
Recall
- Recall Number
- Z-0351-06
- Event Number
- 34082
- Firm
- Merit Medical Systems, Inc
- FEI Number
- 1721504
- Product Code
- MAV
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 7, 2005
- Posted
- January 6, 2006
- Terminated
- March 14, 2006
- Address
- 1600 West Merit Pkwy South, Jordan, UT, 84095-2416
Description
IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
Reason
Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
Action
Sale representatives and consignees were notified by letter.
Distribution
Device was distributed in the US, Canada and worlwide. US distribution includes: AL, IN, MD, MS, NJ, OH, OR, PA, TN, TX, and WA. Foreign consignees include: Argentinal, Australia, Belgium, Brazil, France, Germany, Israel, Japan, Mexico, Netherland, New Zealand, UK and Wales.
Quantity
38 units