Class 2 Device Recall Procedure Kit

• Date Initiated by Firm: September 02, 2005
• Date Posted: October 21, 2005
• Recall Status: Terminated on October 28, 2005
• Recall Number: Z-0077-06
• Recall Event ID: 33364
• 510(K)Number: K913682
• Product Classification: Catheter, Intravascular, Diagnostic - Product Code DQO
• Product: Merit Custom Procedure Kit
• Code Information: Part Number: K08-01894, Lot Number A306856
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc; 1600 West Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-253-1600
• Manufacturer Reason for Recall: Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 9/2/2005.
• Quantity in Commerce: 99 units
• Distribution: DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.
• 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 = DQO