Class 2 Device Recall Prelude Short Sheath Introducer

• Date Initiated by Firm: April 14, 2009
• Date Posted: June 10, 2009
• Recall Status: Terminated on February 09, 2010
• Recall Number: Z-1404-2009
• Recall Event ID: 51877
• 510(K)Number: K082063
• Product Classification: Catheter Introducer - Product Code DYB
• Product: 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-5F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. 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. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
• Code Information: Lot numbers: F620904, F635075, and F661562.
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 Merit Pkwy; South Jordan UT 84095
• For Additional Information Contact: 801-208-4438
• Manufacturer Reason for Recall: External tubing may separate during use, allowing blood loss.
• FDA Determined Cause: Process control
• Action: All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.
• Quantity in Commerce: 294 units
• Distribution: Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.
• 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 = DYB