Class 2 Device Recall ChloraPrep With Tint

• Date Initiated by Firm: July 09, 2018
• Create Date: April 13, 2020
• Recall Status: Terminated on April 14, 2020
• Recall Number: Z-1702-2020
• Recall Event ID: 85171
• Product Classification: Angiography/angioplasty kit - Product Code OEQ
• Product: ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
• Code Information: Merit lot number J559821
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-253-1600
• Manufacturer Reason for Recall: A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm immediately notified the customer on 7/9/2018 to determine if the product had been used.
• Quantity in Commerce: 6 units
• Distribution: US Nationwide distribution in the state of IL. There was no other 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.