Viceroy Inflation Syringe, 60mL, without gauge.
This recall has been terminated (originally issued December 17, 2005).
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- October 21, 2005
- Posted
- December 17, 2005
- Terminated
- May 25, 2006
- Recall Number
- Z-0291-06
- Quantity
- 62 units
- Firm Location
- Jordan, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Inflation device may not hold vacuum during angioplasty procedure.
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.
Lot / Code Info
Catalog Number: V6001. Lot Numbers: F395371, F398796, F404213.
Root Cause
Other
Action Taken
All consignees were notified by fax and letter on 10/21/2005.
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