Z-0291-06

Viceroy Inflation Syringe, 60mL, without gauge

Name: Z-0291-06 Viceroy Inflation Syringe, 60mL, without gauge
Creator: Merit Medical Systems, Inc
Published: 2005-10-21
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2005-10-21 / Terminated

FDA source

Merit Medical Systems, Inc began a recall of Viceroy Inflation Syringe, 60mL, without gauge on 2005-10-21. The reason FDA records is "Inflation device may not hold vacuum during angioplasty procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0291-06
Status: Terminated
Initiated: 2005-10-21
Posted: 2005-12-17
Terminated: 2006-05-25
Recalling firm: Merit Medical Systems, Inc.
Product: Viceroy Inflation Syringe, 60mL, without gauge.
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Inflation device may not hold vacuum during angioplasty procedure.
FDA root cause: Other
Action: All consignees were notified by fax and letter on 10/21/2005.
Quantity in commerce: 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.
Product codes and lots: Catalog Number: V6001. Lot Numbers: F395371, F398796, F404213.

Product code MAV

K040138Class IIViceroy Inflation DeviceMerit Medical Systems, Inc. / cleared 2004-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)