Z-1702-2020 Class II Terminated

Recalled by Merit Medical Systems, Inc. — South Jordan, UT

Recall Details

Product Type
Devices
Report Date
April 22, 2020
Initiation Date
July 9, 2018
Termination Date
April 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

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.

Reason for Recall

A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

Distribution Pattern

US Nationwide distribution in the state of IL. There was no other distribution.

Code Information

Merit lot number J559821