Class 2 Device Recall Prelude Pro Sheath Introducter

• Date Initiated by Firm: June 04, 2015
• Date Posted: June 22, 2015
• Recall Status: Terminated on October 26, 2015
• Recall Number: Z-1826-2015
• Recall Event ID: 71519
• 510(K)Number: K070159
• Product Classification: Dilator, vessel, for percutaneous catheterization - Product Code DRE
• Product: Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO; The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
• Code Information: Catalo Number PR0-6F-11-038, Lot Number H767887
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 West Merit Parkway; South Jordan UT 84095
• For Additional Information Contact: Cory Marsh; 801-316-3690
• Manufacturer Reason for Recall: Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
• FDA Determined Cause: Packaging process control
• Action: Merit Medical sent an Urgent Product Recall letter on June 4, 2015, to all affected consignees. Consignees were instructed to immediately quarantine any affected devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account and a representative copy of communications sent directly to their affected accounts. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department. Customers with questions were instructed to contact their Merit Sales Representative or call (801) 208-4365.
• Quantity in Commerce: 1,445
• Distribution: Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.
• 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 = DRE and Original Applicant = MERIT MEDICAL SYSTEMS, INC.