FDA Recall
Terminated
Viceroy Inflation Syringe, 60mL, without gauge.
Recall: Z-0291-06
·
Initiated October 21, 2005
Recall
- Recall Number
- Z-0291-06
- Event Number
- 33954
- Firm
- Merit Medical Systems, Inc
- FEI Number
- 1721504
- Product Code
- MAV
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 21, 2005
- Posted
- December 17, 2005
- Terminated
- May 25, 2006
- Address
- 1600 West Merit Pkwy South, Jordan, UT, 84095-2416
Description
Viceroy Inflation Syringe, 60mL, without gauge.
Reason
Inflation device may not hold vacuum during angioplasty procedure.
Action
All consignees were notified by fax and letter on 10/21/2005.
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 government or military distribution.
Quantity
62 units