Class 2 Device Recall Merit Medical Custom Prelude IDeal Kit

• Date Initiated by Firm: September 12, 2019
• Create Date: May 11, 2020
• Recall Status: Terminated on May 27, 2022
• Recall Number: Z-1956-2020
• Recall Event ID: 85342
• 510(K)Number: K173750
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
• Code Information: Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: Cory Marsh; 801-253-1600
• Manufacturer Reason for Recall: labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
• FDA Determined Cause: Process control
• Action: A verbal (telephone) notification attempt was made to the customer on September 12th and 13th. These attempts resulted in a voicemail informing the customer of a voluntary product recall and requesting a call back. A hospital employee was reached by telephone on September 17, 2019 and notified of the product recall. The notification included product identification information, instruction to immediately quarantine any devices and to discontinue use and to return product to Merit per the instructions contained in the Customer Response Form (CRF). The CRF and details of the recall were emailed to the hospital per customer request.. Merit Medical Systems, Inc. is conducting a recall of the K21-00031 Custom Prelude IDeal Kit, lot number H1583914, due to the kit including a Prelude EASE sheath assembly rather than the labeled Prelude IDeal sheath assembly. Additionally, the kit has a labeling error in which the unit and carton labeling indicate a 6 French color (green) rather than the correct 4 French color (red). Merit Medical has not received any complaints from customers or any reports of patient harm or injury as a result of this issue. Return the affected products to Merit via Federal Express 2nd Day Air (Acct# 112952756), include the assigned RMA number. Send to Field Assurance Department Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 Attn: RMA# (found in contact information table) For further information contact Merit Customer service at (801) 208-4381 or by email at response@merit.com.
• Quantity in Commerce: 15 kits
• Distribution: US Nationwide distribution in the state of MI.
• 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