Class 2 Device Recall Fluid Administration Set

• Date Initiated by Firm: April 08, 2008
• Date Posted: September 11, 2008
• Recall Status: Terminated on April 06, 2009
• Recall Number: Z-1803-2008
• Recall Event ID: 47880
• 510(K)Number: K915678
• Product Classification: Catheter, biliary, diagnostic - Product Code FPA
• Product: Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
• Code Information: Lot Number F605310
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-208-4119
• Manufacturer Reason for Recall: Convenience kits may contain non-filtered drip chambers
• FDA Determined Cause: Mixed-up of materials/components
• Action: An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter.
• Quantity in Commerce: 95 kits
• Distribution: Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.
• 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 = FPA and Original Applicant = MERIT MEDICAL SYSTEMS, INC.