FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: Viceroy Inflation Syringe, 60mL, without gauge.
- Recall number
- Z-0291-06
- Recalling firm
- Merit Medical Systems, Inc
- Product
- Viceroy Inflation Syringe, 60mL, without gauge.
- Status
- Terminated
- Initiated
- 2005-10-21
- Posted
- 2005-12-17
- Terminated
- 2006-05-25
- 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
- 62 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 government or military distribution.
- Lot, serial or model codes
- Catalog Number: V6001. Lot Numbers: F395371, F398796, F404213.
- 510(k) numbers
- ["K040138"]
- PMA numbers
- not on file
- Product code
- MAV
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28