Recalls / —

—#42794

Product

Viceroy Inflation Syringe, 60mL, Sterile, Rx only.

FDA product code

MAV — Syringe, Balloon Inflation

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K040138

Affected lot / code info

Catalog Number: V6010, Lot Numbers: F395368

Why it was recalled

Inflation device may not hold vacuum during angioplasty procedure.

Root cause (FDA determination)

Other

Action the firm took

All consignees were notified by fax and letter on 10/21/2005.

Recalling firm

Firm

Merit Medical Systems, Inc

Address

1600 West Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2005-10-21

Posted by FDA

2005-12-17

Terminated

2006-05-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.