Recall Z-0290-06 ยท MAV Syringe, Balloon Inflation
Merit Medical Systems, Inc
Viceroy Inflation Syringe, 60mL, Sterile, Rx only.
| Date | Dec 17, 2005 (initiated Oct 21, 2005) |
| Status | Terminated |
| Reason | Inflation device may not hold vacuum during angioplasty procedure. |
| Root cause | Other |
| Action | All consignees were notified by fax and letter on 10/21/2005. |
| Quantity | 243 units |
| Distribution | FL, UT. Foreign distribution to Austria, Cyprus, Czechoslovakia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Israel, Italy, Japan, Jordan, Kuwait, Netherlands, Norway, Poland, Saudi Arabia, Slovenia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE. No g |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040138 | VICEROY INFLATION DEVICE Merit Medical Systems, Inc., Feb 13, 2004 |