ChloraPrep With Tint recalled over sterility concerns

Recall date

July 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Merit Medical Systems, Inc. recalls ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Ski…

Recall number

Z-1702-2020

FDA classification

Class II

Brand / firm

Merit Medical Systems, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.