Class 2 Device Recall Large Bore Male Luer for use in Fluid Administration Sets.

• Date Initiated by Firm: April 17, 2007
• Date Posted: May 31, 2007
• Recall Status: Terminated on May 05, 2008
• Recall Number: Z-0843-2007
• Recall Event ID: 37902
• 510(K)Number: K915678
• Product Classification: IV set - Product Code FMG
• Product: Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095.
• Code Information: Lot Number F524277
• FEI Number: 1721504
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-208-4405
• Manufacturer Reason for Recall: Male luer in fluid administration sets may crack due to inadequate molding process
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.
• Quantity in Commerce: 117 units
• Distribution: CA, IL, NJ, NY. No military, government or foreign 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 = FMG