Class 2 Device Recall Inflation syringe.

• Date Initiated by Firm: October 21, 2005
• Date Posted: December 17, 2005
• Recall Status: Terminated on May 25, 2006
• Recall Number: Z-0290-06
• Recall Event ID: 33954
• 510(K)Number: K040138
• Product Classification: Syringe, Balloon Inflation - Product Code MAV
• Product: Viceroy Inflation Syringe, 60mL, Sterile, Rx only.
• Code Information: Catalog Number: V6010, Lot Numbers: F395368
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc; 1600 West Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-208-4284
• Manufacturer Reason for Recall: Inflation device may not hold vacuum during angioplasty procedure.
• FDA Determined Cause: Other
• Action: All consignees were notified by fax and letter on 10/21/2005.
• Quantity in Commerce: 243 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MAV and Original Applicant = MERIT MEDICAL SYSTEMS, INC.