Recall Z-0351-06 ยท MAV Syringe, Balloon Inflation
Merit Medical Systems, Inc
IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.
| Date | Jan 6, 2006 (initiated Nov 7, 2005) |
| Status | Terminated |
| Reason | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. |
| Root cause | Other |
| Action | Sale representatives and consignees were notified by letter. |
| Quantity | 38 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993341 | INTELLISYSTEM II COLOR MONITOR Merit Medical Systems, Inc., Oct 25, 1999 |