Viceroy Inflation Syringe, 60mL, without gauge.
FDA device recall Z-0291-06 · posted 2005-12-17 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- Inflation device may not hold vacuum during angioplasty procedure.
- Action taken
- All consignees were notified by fax and letter on 10/21/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAV
- Quantity affected
- 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, P
- Date initiated
- 2005-10-21
- Date posted
- 2005-12-17
- Date terminated
- 2006-05-25
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VICEROY INFLATION DEVICE (K040138) | Merit Medical Systems, Inc. | 2004-02-13 |